News

Milestone says heart disorder therapy under FDA review again
Milestone Pharmaceuticals (MIST) stock falls amid a capital raise as FDA agrees to review its resubmitted NDA for heart therapy Cardamyst. Read more here.
BioSpace1h
FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
US FDA declines to approve Capricor's muscle disorder therapy
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.
This EastEnders guest star was rejected by the BBC soap 37 years ago
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 ...
F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
STAT15h
FDA publishes rejection letters sent to drugmakers, with a big caveat
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
US FDA publishes 200 complete response letters from archive in transparency drive
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.
Indianapolis Business Journal20h
FDA begins sharing rejection letters drugmakers often kept secret
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.
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
BioSpace21h
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
Fierce Biotech21h
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...