Regulatory

Synopsis : Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of…

Summary : Vigabatrin is used to treat babies, one month to two years old with infantile spasms. Zydus has received final approval…

Summary : Novo Nordisk said it had invested 15 years of continuous research to make the oral formulation of semaglutide into a…

Summary : The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg…

 Synopsis : With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the…

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

Synopsis : TARZED is considered safe and more efficacious compared to conventional treatment medicines for breast cancer. Cadila Pharmaceuticals Limited on Wednesday…

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

MINUTES OF THE 435th REGISTRATION COMMITTEE MEETING HELD ON 23.12.2021. The 435th meeting of the Registration Committee (RC) was held under the…

Summary : -Abbott, a global healthcare leader, announced that the US Food and Drug Administration (FDA) has approved new expanded magnetic resonance…