Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking ...

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

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 ...

A Regeneron Pharmaceuticals drug that lowers levels of a disease-driving protein has met the goals of a pivotal test in the rare disease generalized myasthenia gravis. Based on these results, ...

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.

OX124 is based on Orexo´s world-class drug delivery platform, amorphOX®, and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl Synthetic opioids are behind 91 ...

VIASKIN patch is designed to introduce microgram amounts of an allergen like peanuts to the immune system through intact skin ...

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 ...

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 ...