FDA Accepts for Review Theravance, Inc. (THRX)'s Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
4/27/2009
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Discovery Laboratories (DSCO) to File Surfaxin Response in 4 Weeks
9/24/2008
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Cardiome Pharma Corp. (COM.TO) And Astellas Pharma Inc. Announce Receipt Of FDA Approvable Letter For KYNAPID(TM)
8/11/2008
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Discovery Laboratories (DSCO) Reports Progress in Responding to Surfaxin FDA Approvable Letter
8/6/2008
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UCB Group (UCBJF.PK) Receives Not-approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain
7/30/2008
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Vanda Pharmaceuticals, Inc. (VNDA) Announces Receipt of Not Approvable Letter From FDA for Iloperidone
7/28/2008
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Eisai Corporation of North America Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures; FDA's Not Approvable Letter Outlines Pathway to Potential Approval
7/28/2008
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NexMed (NEXM) Receives FDA Non Approvable Letter for ED Product
7/23/2008
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Xanodyne Pharmaceuticals, Inc. Receives Approvable Letter From the U.S. FDA for ZIPSOR(TM) Capsules
7/22/2008
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Sciele Pharma, Inc. (SCRX) Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment
7/17/2008
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FDA (JOBS) Revises Process for Responding to Drug Applications
7/10/2008
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Indevus Pharmaceuticals, Inc. (IDEV) Receives Approvable Letter from FDA for NEBIDO(R); Company Announces Revised Operating Plan to Respond to NEBIDO Delay
6/30/2008
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Discovery Laboratories (DSCO) Delays Surfaxin Response to FDA
6/19/2008
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Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase)
6/19/2008
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FDA Requests More Information On Meda AB (SE:MEDAa)'s New Azelastine Formulation
6/4/2008
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Discovery Laboratories (DSCO) and FDA to Meet On June 18, 2008 to Clarify Limited Items in SURFAXIN Approvable Letter
5/29/2008
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Wyeth (WYE) Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia
5/29/2008
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US Delays Approval Of Wyeth (WYE) Osteoporosis Medicine Bazedoxifene
5/23/2008
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Discovery Laboratories (DSCO) Provides Guidance on FDA Approvable Letter for Surfaxin for RDS
5/5/2008
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US Delays Approval for Discovery Laboratories (DSCO)' Surfaxin
5/2/2008
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Merck & Co., Inc. (MRK) Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
4/29/2008
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Schering-Plough Corporation (SGP) and Merck & Co., Inc. (MRK) Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
4/28/2008
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Jerini AG Receives Positive CHMP Opinion Recommending European Approval for Icatibant in the Treatment of HAE; FDA Issues Not Approvable Letter
4/25/2008
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Johnson and Johnson Pharmaceutical R&D (NJ), Basilea Pharmaceutica Key Drug Fails to Get FDA Approval; Stock Dives
3/18/2008
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Astellas Pharma Inc. Sees U.S. Delay on Transplant Drug Advagraf
3/14/2008
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Daiichi Sankyo Co Ltd. Says U.S. FDA Rejects Anaemia Drug
3/12/2008
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Theravance, Inc. (THRX) Says FDA to Review Response on Antibiotic
3/6/2008
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Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
2/28/2008
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FDA Issues Not-Approvable Letter for Eli Lilly and Company (LLY)'s Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
2/28/2008
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Cipher Pharmaceuticals (DND.TO) Receives FDA Response to CIP-TRAMADOL ER Appeal
2/1/2008
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Jazz Pharmaceuticals, Inc. (JAZZ) Says FDA Accepts Additional Data on Luvox
2/1/2008
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IMPAX Laboratories, Inc. (IPXL) Receives FDA Non-Approvable Letter for Vadova(R); Company Considering Options
1/30/2008
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Merck & Co., Inc. (MRK) Receives Not Approvable Letter from FDA for OTC MEVACOR(R) 20 mg
1/28/2008
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FDA Doesn't Overturn Labopharm (DDS.TO)'s Tramadol Ruling
1/24/2008
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FDA Issues Approvable Letter for Jazz Pharmaceuticals, Inc. (JAZZ)'s LUVOX(R) CR Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder
12/26/2007
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Pfizer Inc. (PFE) Receives Approvable Letter from FDA for Dalbavancin
12/26/2007
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Pharmacyclics, Inc. (PCYC) Cancer Drug Not Approvable Says US FDA
12/26/2007
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Wyeth (WYE) Gets Approvable Letter for Osteoporosis Drug
12/26/2007
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Indevus Pharmaceuticals, Inc. (IDEV) Gets Non-Approvable Letter for Cancer Therapy
12/20/2007
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Neurocrine Biosciences, Inc. (NBIX) Gets FDA Approvable Letter for Indiplon
12/13/2007
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FDA Issues Approvable Letter for GlaxoSmithKline (GSK)'s Requip(R) XL (TM) Extended Release Tablets
12/10/2007
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Forest Laboratories, Inc. (FRX) and Mylan Laboratories Inc. (MYL) Get FDA Approvable Letter for Nebivolol
12/3/2007
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Labopharm (DDS.TO) to Appeal FDA's Tramadol Decision
11/26/2007
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Labopharm (DDS.TO) to Appeal FDA's Tramadol Decision
11/21/2007
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U.S. Rejects GlaxoSmithKline (GSK)'s Gepirone ER Antidepressant
11/5/2007
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Pozen, Inc. (POZN) Announces Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
11/1/2007
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Adams Respiratory Therapeutics Says FDA Seeks More Data to OK Cough Drug
10/29/2007
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Noven Pharmaceuticals Inc. (NOVN) Gets FDA Approvable Letter for Stavzor
10/24/2007
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FDA Asks for More Information to OK Theravance, Inc. (THRX) Skin Disease Drug
10/22/2007
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DOR BioPharma, Inc. (DORB) Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host Disease
10/19/2007
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Labopharm (DDS.TO) Appeals FDA's Tramadol Decision
10/15/2007
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Pozen, Inc. (POZN) Submits Response to Approvable Letter for Trexima(TM)
10/15/2007
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Pozen, Inc. (POZN) Plans to Submit Response to Approvable Letter For Trexima(TM) Within the Next Ten Days
10/5/2007
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Amylin Pharmaceuticals, Inc. (AMLN) (Jobs) Says SYMLIN Pen-Injector Devices Use Without Mealtime Insulin Not Approvable
10/1/2007
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U.S. FDA Looks for More Information on Endo Pharmaceuticals (ENDP)'s Frova
10/1/2007
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Discovery Laboratories (DSCO) Release: Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter
10/1/2007
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Novartis International AG (NVS) Painkiller Prexige Gets "Not Approvable" Letter in U.S.
9/27/2007
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IDM Pharma, Inc. (IDMI) Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
8/27/2007
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Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for CREON(R)
8/20/2007
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Indevus Pharmaceuticals, Inc. (IDEV) Gets Approvable Letter for Bladder Cancer Therapy
8/17/2007
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GlaxoSmithKline (GSK) (Jobs) Says FDA has Questions on Restless Legs Drug
8/13/2007
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FDA Deems Wyeth (WYE) (Jobs) and Solvay Pharmaceuticals, Inc. Schizophrenia Drug Not Approvable
8/10/2007
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GlaxoSmithKline (GSK) (Jobs) Receives Not Approvable Letter From FDA on Advair(R) 500/50 for COPD
8/8/2007
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Jazz Pharmaceuticals, Inc. (JAZZ) (Jobs) Says Solvay Pharmaceuticals, Inc. Gives FDA More Luvox Information
8/3/2007
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FDA Issues Second Approvable Letter for Pozen, Inc. (POZN) and GlaxoSmithKline (GSK)'s (Jobs) Trexima(TM); Approval Delayed
8/2/2007
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Wyeth (WYE) (Jobs) Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause; Heart, Liver Concerns with Drug
7/24/2007
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Biovail Corporation (BVF) Provides Update on BVF-033; Receives Non-Approval Letter From FDA
7/20/2007
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Neurochem, Inc. (NRMX) Receives Approvable Letter for Eprodisate (KIACTA(TM)) for Treatment of AA Amyloidosis; FDA Asks for More Data
7/18/2007
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Labopharm (DDS.TO) Says May Need Another Tramadol Trial
6/29/2007
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Shire Pharmaceuticals Group plc (SHPGY) Receives Approvable Letter From FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
6/21/2007
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New Pfizer Inc. (PFE) (Jobs) AIDS Drug Approval Delayed
6/21/2007
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FDA Issues Approvable Letter for Johnson and Johnson Pharmaceutical R&D (NJ)'s (Jobs) RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
6/21/2007
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FDA Issues Third Approvable Letter for Encysive Pharmaceuticals (ENCY)'s Thelin (Sitaxsentan Sodium)
6/18/2007
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Labopharm (DDS.TO) Receives Second Approvable Letter from FDA for Once-Daily Tramadol
6/1/2007
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Roche (RHHBY) Receives Approvable Letter for MIRCERA(R) in the United States; Drug Approval Delayed
5/21/2007
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FDA Issues Approvable Letter for Shire Pharmaceuticals Group plc (SHPGY)'s SPD465 for the Treatment of ADHD in Adults
5/21/2007
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Merck & Co., Inc. (MRK) (Jobs) Receives Approvable Letter from FDA for EMEND(R) (fosaprepitant dimeglumine) For Injection; FDA Seeks More Data
5/14/2007
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Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Receives "Not Approvable" Letter for H.P. Acthar(R) Gel for Treatment of Infantile Spasms
5/14/2007
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Cipher Pharmaceuticals (DND.TO) Receives Approvable Letter from FDA for CIP-TRAMADOL ER
5/4/2007
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Merck & Co., Inc. (MRK) (Jobs) Receives Non Approvable Letter from FDA for Arcoxia (etoricoxib)
4/27/2007
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Cipher Pharmaceuticals (DND.TO) Receives Approvable Letter from FDA for CIP-ISOTRETINOIN; FDA Seeks More Clinical Data
4/27/2007
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Wyeth (WYE) (Jobs) Receives Conditional Approval for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
4/25/2007
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Cephalon, Inc. (CEPH) Says Drug 'Approvable' But Needs Warning
4/2/2007
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Cangene Corporation (CC:CNJ) Receives an Approvable Letter from the FDA for Human Growth Hormone
3/12/2007
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Nuvo Research Inc. (NRI.TO) Announces Further Update on Discussions With the FDA Related to Review of Pennsaid
3/8/2007
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AVANIR Pharmaceuticals (AVNR) (Jobs) Summarizes Outcome of FDA Meeting on Zenvia NDA; Additional Data Needed
2/28/2007
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Nuvo Research Inc. (NRI.TO) Says FDA Approval For Pennsaid May Be Delayed
2/9/2007
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GlaxoSmithKline (GSK) (Jobs) Receives Approvable Letter For New Indications For ARIXTRA(R) (Fondaparinux Sodium) Injection
2/2/2007
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AVANIR Pharmaceuticals (AVNR) (Jobs) Receives FDA Approvable Letter For New Formulation Of Currently Marketed Antipsychotic Drug FazaClo
1/31/2007
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Astellas Pharma Inc. (Jobs) Shares Fall On FDA News On Transplant Drug
1/24/2007
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Wyeth (WYE) (Jobs) Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder
1/24/2007
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Cipher Pharmaceuticals (DND.TO)'s Response To Approvable Letter For CIP-ISOTRETINOIN Accepted For Review By FDA
1/17/2007
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FDA Accepts Labopharm (DDS.TO)'s Response To Approvable Letter For Once-Daily Tramadol As Complete
1/16/2007
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Nuvo Research Inc. (NRI.TO) Receives Approvable Letter From U.S. FDA For Pennsaid
12/29/2006
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GlaxoSmithKline (GSK) Receives Approvable Letter For Topical Antibiotic, Altabax(TM) (retapamulin ointment), 1%
12/26/2006
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New River Pharmaceuticals Inc. (NRPH) And Shire PLC Receive Approvable Letter For VYVANSE(TM) (lisdexamfetamine dimesylate) For The Treatment Of ADHD
12/22/2006
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Allergan Inc. (AGN) Announces FDA Issues Approvable Letter For COMBIGAN(TM) (Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution) 0.2%/0.5%
12/22/2006
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Labopharm (DDS.TO) Submits Response To Approvable Letter For Once-Daily Tramadol To FDA
12/20/2006
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Genta Incorporated (GNTA) Receives Non-Approvable Notice For Application of Genasense(R) In Patients With Chronic Lymphocytic Leukemia
12/15/2006
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Encysive Pharmaceuticals (ENCY) Says FDA Finds Response To Thelin Incomplete
12/14/2006
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FDA Needs More Pozen, Inc. (POZN) Trexima Data; Company To Submit Revised Response To Approvable Letter By Year End
12/13/2006
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Anika Therapeutics (ANIK) Receives FDA Approvable Letter For Its Cosmetic Tissue Augmentation Product
11/29/2006
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FDA Accepts As "Complete Response" Oscient Pharmaceuticals Corporation (OSCI)'s Submission Following FACTIVE Approvable Letter For Five-Day CAP
11/27/2006
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Merck & Co., Inc. (MRK) Responds To FDA-Issued Approvable Letters For Arcoxia(R) (etoricoxib)
11/10/2006
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Pozen, Inc. (POZN) Submits Full Response To FDA Approvable Letter For Trexima(TM)
11/9/2006
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AVANIR Pharmaceuticals (AVNR) Receives FDA Approvable Letter For Zenvia For The Treatment Of Involuntary Emotional Expression Disorder
10/31/2006
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FDA Issues Non-Approvable Letter For Replidyne, Inc.'s Faropenem
10/23/2006
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Adeza Biomedical (ADZA) Receives FDA Approvable Letter For Gestiva
10/23/2006
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Columbia Laboratories, Inc. (CBRX) Comments On FDA Decision On Adeza Biomedical (ADZA)'s Gestiva
10/23/2006
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Amgen (AMGN) Receives Complete Response Letter For Extended Dosing Of Aranesp(R) For Patients With Chronic Kidney Disease And Anemia; FDA Seeks More Data
10/16/2006
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MGI PHARMA, INC. (MOGN) Receives Approvable Letter For Saforis(TM) (Glutamine) Powder in UpTec(TM) For Oral Suspension; FDA Seeks Another Trial Of Saforis
10/13/2006
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FDA Issues Approvable Letter For New River Pharmaceuticals Inc. (NRPH) And Shire Pharmaceuticals (SHPGY)'s NRP104 For The Treatment Of ADHD
10/9/2006
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FDA Issues Approvable Letter For Johnson and Johnson Pharmaceutical Research and Development, LLC (CA)'s Paliperidone ER For The Treatment Of Schizophrenia
10/2/2006
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FDA Issues Approvable Letter To Ortec International Inc. (ORTN.OB) For Use Of Cryopreserved OrCel(R) In Epidermolysis Bullosa Patients' Hand Reconstructions And Donor Sites
9/29/2006
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Labopharm (DDS.TO) Receives Approvable Letter From FDA For Once-Daily Tramadol
9/29/2006
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Axcan Pharma (AXCA) Receives FDA Approval Letter For PYLERA'TM' -Formerly Known As HELIZIDE-, An Innovative 3-in-1 Capsule Triple Therapy For The Eradication Of Helicobacter Pylori
9/29/2006
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FDA Receives Approvable Letter From Oscient Pharmaceuticals Corporation (OSCI) For FACTIVE(R) Tablets For Five-Day Treatment Of Community-Acquired Pneumonia; Regulators Request More Information
9/22/2006
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Uroplasty, Inc. (UPST) Receives FDA Approvable Letter For Macroplastique
9/13/2006
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Sanofi-Aventis (France) (SASY.PA) Gets Non-Approvable Letter From US FDA For Dronedarone
8/31/2006
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EPIX Pharmaceuticals (EPIX) Receives Response From The FDA Regarding Appeal Of Vasovist(TM) Approvable Letters
8/28/2006
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Merck & Co., Inc. (MRK) Provides Preliminary Analyses Of The Completed MEDAL Program For ARCOXIA(TM) (Etoricoxib); Merck Looks Forward To Reviewing The MEDAL Program Data With Regulatory Agencies And Intends To Respond To FDA-Issued ''Approvable'' Letter
8/23/2006
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Merck & Co., Inc. (MRK) Moves Forward With Vioxx Successor
8/23/2006
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Eli Lilly and Company (LLY) Announces Approvable Letter Issued By FDA For Arxxant(TM) (ruboxistaurin mesylate); FDA Requests Further Data Before Approval
8/18/2006
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Neurochem, Inc. (NRMX) Receives Approvable Letter For Eprodisate For Treatment Of AA Amyloidosis; FDA Asks For Additional Data Before Final Approval
8/14/2006
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FDA Extends Review Of EPIX Pharmaceuticals (EPIX)' Appeal Of Vasovist(TM) Approvable Letters
7/28/2006
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Encysive Pharmaceuticals (ENCY) Shares Dive After New Delay On Lung Drug
7/25/2006
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FDA Issues Approvable Letter To Cellegy Pharmaceuticals (CLGY) For Cellegesic(R)
7/10/2006
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EPIX Pharmaceuticals (EPIX) Files Appeal With FDA Regarding Vasovist(TM) Approvable Letters
7/5/2006
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Cephalon, Inc. (CEPH) Gets FDA Approvable Letter For Fentora
6/30/2006
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Wyeth (WYE) Contraceptive Delayed By Conditional Approval
6/29/2006
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Neurocrine Biosciences, Inc. (NBIX) Sleep Pill Indiplon May Need More Tests; Shares Plummet
6/16/2006
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Baxter Healthcare Corporation (BAX) Receives Tentative FDA Approvals For Ondansetron Injection In Vials And Premix Containers
6/16/2006
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Pozen, Inc. (POZN) And GlaxoSmithKline (GSK) Report Receipt Of Approvable Letter For Investigational Migraine Treatment; FDA Requests Additional Safety Information
6/9/2006
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Akzo Nobel N.V. (AKZOY) Menopause Treatment Denied U.S. Approval
6/2/2006
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Neurocrine Biosciences, Inc. (NBIX) Receives Approvable Letter For Indiplon Capsules And NON-Approvable For Indiplon Tablets For The Treatment Of Insomnia; Shares Plunge
5/16/2006
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Advancis Pharmaceutical Corporation Receives FDA Approval Letter For New Strengths Of Keflex
5/15/2006
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Cephalon, Inc. (CEPH) Receives Approvable Letter For NUVIGIL(TM) (Armodafinil)
5/2/2006
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The European Medicines Agency Recommends Sanofi-Aventis (France) (SASY.PA) Weight-Loss Pill
4/28/2006
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Chembio Diagnostics, Inc. (CEMI.OB) Receives FDA Approvable Letter For Its Rapid HIV Tests
4/19/2006
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Salix Pharmaceuticals, Ltd. (SLXP)'s MoviPrep(R) Issued Approvable Letter By FDA
4/11/2006
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FDA Gives GlaxoSmithKline (GSK) Tentative OK For OTC Diet Drug
4/10/2006
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FDA Seeks More Data On Discovery Laboratories (DSCO)'s Drug Surfaxin
4/5/2006
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FDA Issues Approvable Letter For Cubist Pharmaceuticals, Inc. (CBST)'s CUBICIN sNDA
3/27/2006
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Encysive Pharmaceuticals (ENCY) Shares Fall After FDA Asks For More Clinical Trial Data For Thelin Approval
3/27/2006
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NPS Pharmaceuticals, Inc. (NPSP) Receives Approvable Letter For PREOS NDA
3/10/2006
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Schwarz Pharma Has Approvable FDA Letter For Neupro
3/1/2006
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Novartis Corporation (NVS) Gets FDA Approvable Letter For Aclasta
2/27/2006
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Sanofi-Aventis (France) (SASY.PA) Received From The FDA An Approvable Letter For Rimonabant For Weight Management And A Non Approvable Letter For Smoking Cessation; Sanofi Shares Fall
2/20/2006
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FDA Issues Approvable Letter For Alkermes (ALKS)' VIVITROL(TM) (Formerly VIVITREX(R)), For The Treatment Of Alcohol Dependence
12/29/2005
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Shire Pharmaceuticals (SHPGY) Receives FDA Approvable Letter For DAYTRANA(TM) For The Treatment Of ADHD
12/27/2005
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MGI Pharma Inc. (MOGN) And SuperGen, Inc. (SUPG) Release: Dacogen(TM) (Decitabine) Injection Complete Response Accepted For Review By U.S. FDA
12/16/2005
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Trimeris, Inc. (TRMS) And Roche (RHHBY) Release: FDA Issues Approvable Letter In Response To Application For Use Of FUZEON With Needle-Free Injection Device
11/28/2005
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FDA Issues Approvable Letter For EPIX Pharmaceuticals (EPIX) Blood-Pool Contrast Agent Vasovist(TM); US Regulators Want Another Trial
11/23/2005
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SuperGen, Inc. (SUPG) And MGI Pharma Inc. (MOGN), Pull European Drug Application
11/15/2005
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Celgene (CELG) Receives Approvable Letter From FDA For THALOMID(R) In Treatment Of Newly Diagnosed Multiple Myeloma; FDA Requests Labeling Changes
11/15/2005
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FDA Rejects PPD, Inc. (PPDI) And Johnson & Johnson (JNJ)'s Premature Ejaculation Drug
10/27/2005
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Cephalon, Inc. (CEPH) ADHD Drug Takes Step Closer To Approval
10/21/2005
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Bristol-Myers Squibb Company (BMY) And Merck & Co., Inc. (MRK) Say FDA Seeks More Data On Pargluva
10/18/2005
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Insmed Incorporated (INSM) Submits Response To FDA Approvable Letter For iPlex
10/18/2005
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Valeant Pharmaceuticals International's (VRX) Zelapar "Approvable" By FDA
10/4/2005
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Insmed Incorporated (INSM) Issues Statement Regarding IPLEX(TM) Approvable Letter Press Release
9/29/2005
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Insmed Incorporated (INSM) Receives Approvable Letter For iPlex(TM)
9/28/2005
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Abbott Laboratories (ABT) Release: FDA Advisory Committee Does Not Recommend Approval Of Xinlay(TM) (atrasentan)
9/14/2005
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Pfizer Inc. (PFE) Says FDA Doesn't Approve Osteoporosis Drug
9/13/2005
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Cephalon, Inc. (CEPH) Receives FDA Approval To Market Sugar-Free Formulation Of ACTIQ(R)
9/13/2005
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MGI Pharma Inc. (MOGN) And SuperGen, Inc. (SUPG): Approvable Letter Received From The FDA For Dacogen(TM) (Decitabine) Injection For The Treatment Of MDS; FDA Asks For More Info
9/2/2005
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Barr Pharmaceuticals, Inc. (BRL) Says Oral Contraceptive Gets Approvable Letter
8/18/2005
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FDA Says It Needs More Information From Discovery Laboratories (DSCO)
8/15/2005
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Teva Pharmaceutical Industries Limited (TEVA) Receives Follow-Up Approvable Letter From FDA Regarding Agilect(R); Concerns Remain
8/5/2005
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Discovery Laboratories (DSCO) Submits Response To FDA Approvable Letter For Surfaxin For RDS In Premature Infants
8/1/2005
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Spanish Biotechnology Company, Cellerix, S.L., Receives Orphan Status Designation By The European Medicines Evaluation Agency For A Stem Cell Medicinal Product
7/29/2005
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STAAR Surgical (STAA) Receives Approvable Letter From FDA For VISIAN ICL(TM)
7/29/2005
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Mentor Corporation (MNTR) Receives "Approvable Letter" From FDA For Its MemoryGel Silicone Gel-Filled Implants
7/29/2005
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Forest Laboratories, Inc. (FRX) Announces FDA Decision On Supplemental New Drug Application For Namenda(R): A Non-Approvable Letter
7/26/2005
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Adolor Corporation (ADLR) Receives FDA Approvable Letter For Entereg(R) (Alvimopan); FDA Requests Additional Studies
7/22/2005
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Chiron Corporation (CHIR) Release: FDA Requests Additional Data On PULMINIQ(TM) (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States That PULMINIQ Is "Approvable" But Additional Study Is Required
7/15/2005
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Johnson and Johnson Pharmaceutical Research and Development, LLC (CA) Receives Not Approvable Letter From FDA For Tipifarnib Based On Phase II Data
7/1/2005
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FDA Accepts EPIX Pharmaceuticals' (EPIX) Submission Following Vasovist(TM) Approvable Letter As Complete Response; FDA Action Targeted For Late November 2005
7/1/2005
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Penwest Pharmaceutical (PPCO) Receives Non-Approvable Letter From FDA For PW2101; Cease Development Of Drug
6/30/2005
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FDA Advisory Panel Voted Abiomed's (ABMD) AbioCor(R) Submission Did Not Yet Meet HDE Standards; Additional Data Is Requested
6/24/2005
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Connetics Corporation (CNCT) Receives FDA Non-Approvable Letter For Velac; Shares Plunge
6/13/2005
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Connetics Corporation (CNCT) To Resume Extina Development With New Phase III Trial
6/8/2005
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Mylan Laboratories Inc. (MYL) Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol
6/1/2005
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La Jolla Pharmaceutical Company (LJPC) Provides Update On Riquent; Warns Of Financing Shortage
5/31/2005
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Johnson and Johnson Pharmaceutical R&D (NJ) Receives Not Approvable Letter For RISPERDAL(R) In The Treatment Of Psychosis Of Alzheimer's Disease
5/26/2005
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Barrier Therapeutics, Inc. (BTRX) Receives Not Approvable Letter From The FDA For Zimycan(TM)
5/25/2005
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Alcon Laboratories, Inc. (ACL) Receives Approvable Letter From FDA For RETAANE Suspension
5/25/2005
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EPIX Pharmaceuticals (EPIX) Submits Response To FDA Approvable Letter For MS-325; Conference Call And Webcast Scheduled
5/23/2005
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Johnson and Johnson Pharmaceutical R&D (NJ) Receives Not Approvable Letter On RISPERDAL(R) In The Treatment Of Autism
5/20/2005
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Biovail Corporation (BVF) Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version To Provide Treatment Option For Those Who Suffer From Moderate To Moderately Severe Pain
5/6/2005
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Alpharma Inc. (ALO) Receives FDA Approvable Status For Kadian(R) 200MG Capsules
5/5/2005
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Artes Medical Inc. Begins Qualification Of U.S. Manufacturing Of ArteFill; Company Takes Significant Next Step Toward Final FDA Approval
4/27/2005
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Barr Pharmaceuticals, Inc.'s (BRL) Receives Not Approvable Letter For Bijuva(TM) Vaginal Cream
4/26/2005
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Cellegy Pharmaceuticals (CLGY) Responds To FDA Inquiries Concerning Cellegesic(TM)
4/18/2005
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Sanofi-Aventis (France) (SASY.PA) Release: FDA Issues Approvable Letter For AMBIEN CR(TM) (Zolpidem Tartrate Extended Release) CIV For The Treatment Of Insomnia
4/11/2005
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Cyberonics Inc. (CYBX) Announces Conference Call To Discuss Closure Of FDA Warning Letter
4/7/2005
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Forest Laboratories, Inc. (FRX) Receives Non-Approvable Letter For Social Anxiety Disorder Indication For Lexapro(R)
3/31/2005
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Biovail Corporation (BVF) Updates Status Of NDA For Tramadol ER; Additional Clinical Trial Data Will Be Required
3/30/2005
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Cephalon (CEPH) Receives Approvable Letter To Market Sugar-Free Formulation Of ACTIQ(R)
3/25/2005
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Advanced Magnetics (AVM) Receives Approvable Letter From FDA For Combidex(R)
3/24/2005
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