Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...

The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.

US-based biotechnology company Ocugen has received approval from the Data and Safety Monitoring Board (DSMB) to begin dosing ...

The Food and Drug Administration (FDA) has approved Arbli™, an oral suspension formulation of losartan potassium.  Arbli, an angiotensin II receptor ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.

With a U.S. green light for its encapsulated cell therapy technology in the bag, privately held biotech Neurotech ...

Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) ...

The Food and Drug Administration unexpectedly canceled an annual meeting of its advisers to update next season's influenza vaccines, an adviser on the panel and multiple officials tell CBS News ...

The Union Cabinet, led by Prime Minister Narendra Modi, has approved the proposed amendments to the Waqf (Amendment) Bill after incorporating changes recommended by the Joint Parliamentary ...

The case, called Missouri et al. v. FDA, is a revamped version of a lawsuit filed by anti-abortion groups and doctors in 2023 seeking to block the Food and Drug Administration’s (FDA) approval ...

Google wasn't allowed to unlock that feature in the US until it got regulatory approval, but the Food and Drug Administration has finally given Google the go-ahead to activate Loss of Pulse Detection.

the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses. The agency announced on Monday that it was eliminating a requirement that patients ...