FDA selected seven participants from 80+ requests using a scoring rubric emphasizing supply need, facility development stage, time-to-market, and manufacturing innovation. Amneal will make sterile ...

The U.S. Food and Drug Administration (FDA) on Monday named seven companies selected for its FDA PreCheck Pilot Program. The ...

More than 120 new Florida laws kick in on Wednesday, July 1. Some are minor changes, but some you need to know now.

A Houston-based law firm is undermining a federal law intended to protect victims of domestic abuse by running a highly profitable scheme that encourages clients to file false claims for immigration ...

Gujarat, under CM Bhupendra Patel, leverages PM GatiShakti for tech-driven governance. A new digital platform has streamlined infrastructure NOCs, processing 11,000+ approvals and accelerating ...

(car rushes by) (water sloshes) (road sounds) CAROL HIGHSMITH: Look how gorgeous that is... MAN: Yeah. CAROL: Oh, man. ♪ Man, I mean it's just one shot after another. It's like nothing I've ever seen.

FDA names companies domestic drug manufacturing pilot participants to enhance early regulatory engagement and streamline review processes.

Phase III P304 (n=40,805) showed 26.6% relative efficacy versus standard-dose influenza vaccine for RT-PCR-confirmed influenza-like illness, increasing to 47.9% when anchored to higher-acuity ...

An independent research firm is reviewing data on Amgen’s Tavneos as the company prepares for a hearing with the FDA which could determine whether the rare disease treatment remains on the market. In ...

UniQure still needs to reach an agreement with the FDA on the path to full approval. (Stock Photo ) The FDA has pulled a U-turn on uniQure’s Huntington’s disease gene therapy, giving the biotech the ...

SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S.