FDA Approvals

ViiV Healthcare announced that the US FDA has approved a supplemental New Drug Application (sNDA) for dolutegravir 10mg and 25mg oral tablets, reducing the...

NATCO Pharma Limited receives USFDA tentative approval for Sorafenib Tablets, 200mg

FDA Approvals

Natco Pharma Limited announced that its marketing partner, Mylan Inc has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib...

FDA approves For Eisais Anticancer Agent Lenvima In Combination With Everolimus as Treatment For advanced Renal Cell Carcinoma

FDA Approvals

Eisai Co Ltd announced that its U.S. subsidiary Eisai Inc. has received approval from the U.S. FDA for an additional indication for Eisai's in-house...

Sun Pharma Receives USFDA Approval For BromSite

FDA Approvals

Sun Pharma announced that one of its wholly owned subsidiaries has received approval from USFDA for its New Drug Application (NDA) related to BromSite™...

Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes

FDA Approvals

Novartis announced that the US Food and Drug Administration (FDA) has granted three Breakthrough Therapy Designations for Ilaris® (canakinumab) to treat three rare types...

Merck Receives Breakthrough Therapy Designation from U.S. FDA for KEYTRUDA in Classical Hodgkin Lymphoma (cHL)

Americas

Merck, known as MSD outside the United States and Canada, announced that the U.S. FDA has granted Breakthrough Therapy Designation to KEYTRUDA® (pembrolizumab), the...

Merck’s BRIDION® (sugammadex) Receives FDA Approval for the Reversal of Neuromuscular Blockade Induced by Rocuronium and Vecuronium in Adults Undergoing Surgery

FDA Approvals

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved...

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