News

FOX 5 Atlanta11h
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.
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 ...
Investor's Business Daily on MSN14h
Capricor Therapeutics Hammered On A Surprise FDA Rejection
Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...
Applied Clinical Trials Online17h
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 ...
Fierce Pharma20h
‘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 Advisor20h
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.
BioPharma Dive21h
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.
KFF Health News21h
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 ...
Fierce Biotech21h
FDA rejects Capricor’s DMD cell therapy, asks for more data
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
BioSpace21h
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.
BioSpace23h
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 ...