USFDA

Summary: Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug…

Summary : The expert panel of India’s central drug authority on Monday recommended granting restricted Emergency Use Authorisation (EUA) to Biological E’s…

Summary : Drug firm Lupin on Wednesday said it has entered into a distribution pact with Slovenia-based Medis for its orphan drug…

Summary : The U.S. Food and Drug Administration approved Sanofi’s proposed drug to address red blood cell destruction in patients living with…

SUMMARY – Last year, GlaxoSmithKline’s ViiV Healthcare’s feat of getting a long-awaited approval of HIV treatment by the name of Cabenuva was…

Summary : This week, Gilead Sciences took a $1.25 billion hit after reaching a settlement with ViiV Healthcare on a patent dispute…

Synopsis : Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Amphetamine mixed…

Synopsis: Lupin stated that its US-based unit has inked a pact with Exeltis Inc to promote Solosec, a drug used to treat…

Summary : Marksans Pharma Limited (Reuters: MARK.BO; Bloomberg: MRKS IN; NSE: MARKSANS; BSE: 524404) has received final approval from US Food &…

Synopsis: Jubilant Therapeutics Inc, a biopharmaceutical company, announced US Food and Drug Administration (FDA) clearance of the investigational new drug application (IND)…