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SUBSCRIBE

Approvals

FDA
Sinovac Biotech Ltd. Granted SFDA Approval for Avian Flu Vaccine
April 2, 2008
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1 min read
FDA
Oculus Innovative Sciences, Inc. Announces SFDA Approval of Microcyn
March 31, 2008
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1 min read
FDA
Study Shows FDA Deadlines Affect Drug Safety
March 27, 2008
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1 min read
FDA
U.S. Advisers: Restrict Amgen, Johnson & Johnson Anemia Drugs
March 24, 2008
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1 min read
FDA
FDA Gives Itself Okay To Miss Some Drug Approval Deadlines
March 24, 2008
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1 min read
FDA
China Medical Technologies, Inc. Granted CE Mark for ECLIA Analyzer
March 24, 2008
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1 min read
FDA
Tianyin Pharmaceutical Co, Inc. Wins SFDA Approval for Antibiotic
March 17, 2008
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1 min read
FDA
FDA Panel OKs 3 New Flu Strains for Next Year’s Vaccine
February 22, 2008
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1 min read
FDA
More Evidence of Danger From Bayer AG Heart Surgery Drug
February 21, 2008
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1 min read
FDA
US FDA to Review Vytorin Cholesterol Drug Study
January 28, 2008
 · 
1 min read
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PRESS RELEASES
FDA
Sedative that Received FDA Emergency Use Authorization Now Available from Fresenius Kabi for use in Mechanically Ventilated COVID-19 patients
June 15, 2020
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6 min read
Drug Development
Arch Biopartners Announces FDA Acknowledgement of its Investigational New Drug Application for Metablok (LSALT peptide)
June 15, 2020
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5 min read
FDA
FDA Approves JUVÉDERM® VOLUMA™ XC for Enhancement of the Chin Region
June 15, 2020
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7 min read
FDA
FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers
June 12, 2020
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9 min read
FDA
FDA Approves Drug to Treat Infants and Children with HIV
June 12, 2020
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4 min read
FDA
ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV
June 12, 2020
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12 min read
FDA
Dr. Reddy’s Laboratories Announces the Launch of Colchicine Tablets USP, 0.6 mg in the U.S. Market
June 12, 2020
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3 min read
FDA
Mylan and Biocon Announce U.S. FDA Approval of Semglee™ (insulin glargine injection)
June 11, 2020
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14 min read
FDA
FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord
June 11, 2020
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3 min read
FDA
Leap Therapeutics Announces Oprhan Drug Designation of DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer
June 11, 2020
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5 min read
FDA
MiRus™ Announces First Clinical Use of the MiRus™ 3DR™ Printed Lumbar Interbody Fusion System
June 11, 2020
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3 min read
FDA
FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)
June 11, 2020
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10 min read
FDA
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy
June 10, 2020
 · 
20 min read
FDA
Hematogenix Announces the Availability of COVID-19 Antibody Testing
June 10, 2020
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3 min read
FDA
FDA Issues Emergency Use Authorization for ChromaCode’s High-Throughput HDPCR™ SARS-CoV-2 Real-Time PCR Assay
June 10, 2020
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3 min read
FDA
Curis Announces FDA Clearance of IND Application for CI-8993, the First-In-Class Monoclonal Anti-VISTA Antibody
June 10, 2020
 · 
8 min read
FDA
Quidel Receives Amended Emergency Authorization for Rapid Antigen COVID-19 Diagnostic Assay Using Sofia 1 Instrument
June 9, 2020
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8 min read
FDA
MIVI Neuroscience Announces FDA IDE Clinical Study Approval For the MIVI Q Aspiration Catheter
June 9, 2020
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2 min read
FDA
U.S. Food & Drug Administration Grants 510(k) Clearance For Vasoptic Medical’s Retinal Imaging Device
June 9, 2020
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3 min read
FDA
4WEB Medical Announces FDA 510(k) Clearance of Stand-Alone Anterior Lumbar Interbody Fusion Device
June 9, 2020
 · 
2 min read
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