Tag: America
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FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma
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...
Aurobindo Pharma receives FDA approval for Dolutegravir, Lamivudine & Tenofovir Disoproxil tablets
Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the U.S. FDA under the U.S. President’s Emergency Plan...
Aurobindo Pharma receives USFDA Approval for Sevela mer Carbonate tablets
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture...
First FDA-Approved Treatment for ALS in 22 Years Now Available in U.S
Mitsubishi Tanabe Pharma America, Inc. announced RADICAVA ™ (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as...
Lexicon Collaborator Ipsen Receives Positive Chmp Opinion For Xermelo
Lexicon Pharmaceuticals, Inc. , announced that the Committee for Medicinal Products for Human Use (CHMP), the committee of the European Medicines Agency (EMA) responsible...
