Milestone Pharmaceuticals (MIST) stock falls amid a capital raise as FDA agrees to review its resubmitted NDA for heart therapy Cardamyst. Read more here.

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.

A new EastEnders guest star has revealed she was previously rejected by the soap 37 years ago. Shazia Mirza appears in today's episode of the BBC soap as Dr Ayub, who is involved in the baby Jimmy ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...