InvestorsHub on MSN

FDA accepts Cogent’s drug filing for treatment of rare blood disorder

Cogent Biosciences Inc. (NASDAQ:COGT) said the U.S. Food and Drug Administration has accepted its New Drug Application for ...

ImmunityBio Highlights ANKTIVA Surge, FDA Papillary Filing and Key 2026 Milestones at Conference

CEO Richard Adcock used a presentation at the Citizens Life Sciences Conference to outline the company’s commercial progress ...
Seeking Alpha

FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity

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 ...
Stocktwits on MSN

Cingulate stock jumps overnight: US Patent Office clears ADHD drug filing ahead of May FDA catalyst

The USPTO cleared a patent filed in November 2023, with a status indicating it has been approved and the patent is expected ...
pharmaphorum

Vertex preps FDA filing for IgAN drug after phase 3 readout

Interim results from RAINIER reveal that an 80 mg dose of povetacicept every four weeks delivered a 52% reduction in protein ...
Benzinga.com

MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars

MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
La Grande Observer

GeminiBio Submits Drug Master File (DMF) to FDA

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 ...