Establishment Labs ESTA recently announced that it has submitted its Motiva breast implants to the FDA for approval in ...

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational ...

Early Thursday, Takeda revealed top-line data for two pivotal phase 3 trials of its next-gen, highly selective oral tyrosine ...

On December 24, 2025, Sanofi announced that the US Food and Drug Administration issued a complete response letter for its new drug application for tolebrutinib to treat non-relapsing secondary ...

The biologics center director reportedly became personally involved after the team reviewing the rare blood disorder filing asked for an extension to the CNPV-accelerated timeline.

Transplants can trigger EBV reactivation, leading to EBV-positive PTLD, with poor survival if rituximab fails. Tabelecleucel (tab-cel) shows promise in treating refractory EBV+ PTLD, with significant ...

The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.

WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...

CAMBRIDGE, Mass., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB) and Sage Therapeutics, Inc. (SAGE) announced the U.S. Food and Drug Administration (FDA) has accepted the filing ...