The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.

Schwartz will step into an agency that has been without a permanent leader for almost a year amid RFK Jr.’s tumultuous tenure ...

An FDA nod mostly clears the way for Orzeyful to enter, by Wall Street estimates, a multibillion-dollar market for drugs that ...

The clearance paves the way for the first preventive flu shot based on mRNA technology and completes a dramatic regulatory ...

Braveheart is one of five biotechnology firms that made plans to price an IPO this week, bringing in total what could ...

Regulators say the telehealth company illegally shared patients’ health data with advertisers and misled its customers. Hims ...

The startup is the 12th drug company to bank at least $250 million in an IPO this year, nearly matching totals last seen ...

A research disappointment and a miss on Wegovy pill sales hurt Novo, while Lilly’s injectable franchise once again surpassed ...

Despite another strong earnings report, analysts warned that upcoming cystic fibrosis data from Sionna Therapeutics "looms ...

In fact, the former lost tens of billions of dollars in market value following reports of a potential tie-up between the ...

Hatched three years ago, the restructuring is now expected to deliver $1 billion in new cost reductions and save Pfizer ...

The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss ...