US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head ...

Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with ...

From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to ...

The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.

The number of biopharma professionals let go has increased year over year for three straight months. In July, nearly 8,000 ...

Since becoming Vertex's top scientist in 2015, Altshuler has helped the company become an industry powerhouse. He’ll depart ...

The FDA's top vaccine official is stepping down after just 3 months in a role that upset drug companies, patient groups and some political leaders.

President Trump's executive order to "identify and take appropriate action to correct past misconduct by the Federal Government related to censorship of protected speech" is good enough, DOJ tells ...

Hearing minnow Audeara has entered an alliance with Ear Science Institute Australia to develop a more affordable ...

The global cancer gene therapy market size was US$ 1.5 billion in 2021. The global cancer gene therapy market is expected to grow to US$ 3.1 billion by 2030 by registering a compound annual growth ...

Investing.com -- US Food and Drug Administration Commissioner Marty Makary is attempting to convince Vinay Prasad, who recently left his position as head of gene therapy and vaccines, to return to the ...

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect ...