News

Fierce Pharma13h
‘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 | ...
BioSpace14h
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 ...
Applied Clinical Trials Online10h
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...
Makary Reveals What's Broken Inside the FDA
After 100 days as FDA Commissioner, Dr. Marty Makary lays out his vision for reform, starting with the broken systems he's ...
BioSpace16h
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 ...
Investor's Business Daily on MSN6h
Capricor Therapeutics Hammered On A Surprise FDA Rejection
Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...
FDA funding clash looms between Senate, House
Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...
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.
South Florida Reporter22h
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.
BioPharma Dive13h
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.
FOX 5 Atlanta on MSN4h
Georgia lawmakers unite to urge FDA reversal on drug denial for child with rare disease
Georgia's congressional delegation is advocating for FDA reconsideration of the drug elamipretide for Hope Filchak.
Capricor Sinks After FDA Rejects Drug for Muscle Disease
Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...