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Capricor Therapeutics Hammered On A Surprise FDA Rejection
Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...
Fierce Pharma1d
‘Weak evidence’ and an ‘unpleasant’ odor: FDA sheds light on drug refusal process
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...
Infectious Disease Advisor1d
FDA Publishes Full Texts of Response Letters to Drug Applications
The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.
BioSpace1d
FDA 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 ...
BioPharma Dive1d
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
KFF Health News1d
FDA Posts 200 Letters Citing Initial Concerns About Approved Drugs
The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...
BioSpace1d
Capricor Plunges on FDA Rejection of DMD Cell Therapy
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
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.
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.
STAT1d
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.
Indianapolis Business Journal2d
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.