FDA Approvals

Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug...

AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix

Americas

AbbVie , a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.announced that the U.S. FDA has granted priority review...

FDA Approval And Launch Of Generic Renvela® (Sevelamer Carbonate) Tablets, 800 Mg announces impax

Americas

Impax Laboratories, Inc., a specialty pharmaceutical company, announced it has received final U.S. FDA approval on its ANDA for a generic version of Renvela®...

NeuroRx awarded FDA Fast Track Designation for first drug regimen targeting suicide in bipolar depression

FDA Approvals

NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), has been granted Fast Track status by...

Adamas Announces FDA Approval of GOCOVRI as First and Only Medication for the Treatment of Dyskinesia in Parkinson’s Disease Patients

FDA Approvals

Adamas Pharmaceuticals, Inc. announced that the U.S. FDA has approved GOCOVRI extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's...

Sanofi Receives Tentative FDA Approval of Admelog 100 Units/mL

Americas

Sanofi announced that the U.S. FDA granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated...

FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

Americas

Genentech, a member of the Roche Group , announced that the U.S. FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted...

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