Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the ...

After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, ...

Biopharma leaders react to the forced resignation of CDER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; ...

J&J and its subsidiary, Red River Talc, had proposed a $9 billion bankruptcy package to settle cancer claims linked to its ...

Tuesday sued the Department of Health and Human Services over a planned $11 billion funding cut for public health projects.

With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, ...

Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink ...

Organon’s workforce cuts come several months after the company’s loss of exclusivity to its second-largest product, Atozet.

Already reeling from years of market chaos, the announced departure of CBER chief Peter Marks sent a ripple across biopharma ...

BMO Capital Markets analysts said the results potentially position lepodisiran as “one of the most durable assets in ...

The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were ...

Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down ...