FDA Approvals

Roche announced that new data on OCREVUS™ in people with relapsing forms of multiple sclerosis (RMS) and primary progressive MS (PPMS) will be presented...

Teva announces FDA approval of Austedo tablets for chorea associated with huntington’s disease

FDA Approvals

Teva Pharmaceutical Industries Ltd. announced that the U.S. FDA has approved AUSTEDO™ (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease (HD)....

FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review

Americas

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. announced that the US FDA has...

Zimmer Biomet Announces FDA Approval of Gel-One Cross-Linked Hyaluronate

FDA Approvals

Zimmer Biomet Holdings Inc , a global leader in musculoskeletal healthcare announced that the U.S. FDA approved an expanded 26-week efficacy claim for its...

Senhwa Biosciences gets Orphan Drug Designation from US FDA for CX-4945

FDA Approvals

Senhwa Biosciences, Inc. announced that the U.S. FDA has granted Orphan Drug Designation to CX-4945 for the treatment of cholangiocarcinoma. ...

FDA approves Synjardy XR tablets for adults with type 2 diabetes

FDA Approvals

The US FDA has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet...

FDA approves Novo Nordisk’s diabetes drug

Americas

Novo Nordisk A/S said the U.S. FDA approved on Monday its diabetes drug, Xultophy.The Danish drug maker said it planned to launch the drug...

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