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Approvals

FDA
FDA Declares Cloned Meat, Milk Safe
January 15, 2008
 · 
1 min read
FDA
FDA: “Bio-identical” Hormone Claims Unsupported
January 10, 2008
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1 min read
FDA
Approval for Once-A-Day HIV Pill
December 18, 2007
 · 
1 min read
FDA
AlphaRx Inc. Receives SFDA Approval for Topical Arthritis Product
December 10, 2007
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1 min read
FDA
Scanners OK’d for Doctors’ Offices
November 8, 2007
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1 min read
FDA
China Pharma Wins FDA OK for Generic HIV Pill
October 10, 2007
 · 
1 min read
FDA
New Diabetes Drug from Lizard Approved in India
October 1, 2007
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1 min read
FDA
FDA Takes Caution on Approving New Drugs
August 20, 2007
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1 min read
FDA
U.S. Approves 13 Generic Versions of Sleep Drug, Alternative to Sanofi-Aventis (France)'s Ambien
April 24, 2007
 · 
1 min read
FDA
FDA Set to Approve Controversial Cow Drug: Could Hurt Human Health
March 5, 2007
 · 
1 min read
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PRESS RELEASES
FDA
Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the OSOM® Ultra Plus Flu A&B Test
June 9, 2020
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2 min read
FDA
Germicidal Ultraviolet Light by ATOMIC BLUE LLC approved by FDA
June 9, 2020
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1 min read
Drug Development
Immunic, Inc. Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
June 9, 2020
 · 
6 min read
FDA
Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial
June 9, 2020
 · 
4 min read
FDA
Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
June 8, 2020
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3 min read
Business
CEFALY Technology Partners with AZOVA Telemedicine Platform for Virtual Migraine Treatment Prescriptions
June 8, 2020
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2 min read
FDA
Neurelis Announces Rapid and Broad Payer Coverage of the Company’s Flagship Product, VALTOCO® (Diazepam Nasal Spray)
June 8, 2020
 · 
7 min read
FDA
Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)
June 8, 2020
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11 min read
Drug Development
Sound Pharma advances pivotal Phase 3 clinical trials in Meniere’s Disease
June 8, 2020
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4 min read
FDA
Phosphorus Announces FDA Approval Of At-Home Saliva Test For COVID-19
June 8, 2020
 · 
3 min read
FDA
MacroGenics Announces Margetuximab Granted Orphan Drug Designation in the U.S. for Gastric Cancer
June 5, 2020
 · 
5 min read
FDA
FDA Approves Abiomed’s First-in-Human Trial of Impella ECP, World’s Smallest Heart Pump
June 5, 2020
 · 
7 min read
FDA
FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
June 5, 2020
 · 
13 min read
FDA
FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
June 4, 2020
 · 
3 min read
FDA
TVAX Biomedical Receives Fast Track Designation from the FDA for Brain Cancer
June 4, 2020
 · 
2 min read
FDA
QINLOCK (Ripretinib), FDA Approved for Treatment of Gastrointestinal Stromal Tumors (GIST), Available at Biologics by McKesson
June 4, 2020
 · 
2 min read
FDA
FDA Approves Elixirgen Therapeutics IND Application for Therapy for Telomere Biology Disorders with Bone Marrow Failure
June 4, 2020
 · 
2 min read
FDA
Novadoz Pharmaceuticals FDA Approvals of Oseltamivir and Dofetilide Continues the Company’s Rise in the Generic Market
June 4, 2020
 · 
2 min read
FDA
U.S. FDA Accepts PharmaEssentia’s Application for Ropeginterferon Alfa-2b to Treat Polythycemia Vera
June 4, 2020
 · 
7 min read
FDA
Aldeyra Therapeutics Reaches Agreement with the US Food and Drug Administration for the Use of RASP as an Objective Sign for the Treatment of Dry Eye Disease
June 4, 2020
 · 
8 min read
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