News

FierceBiotech29d
Clinical trial diversity nonprofit launches with FDA, Big Pharma vets on its board
Former FDA leader Janet Woodcock, M.D., is also on the CTAC’s board, along with Big Pharma vet Freda Lewis-Hall, M.D., who most recently spent 11 years at Pfizer. The CTAC spent its trial period ...
Reuters24d
FDA halts Rocket Pharma's gene therapy trial as patient dies
May 27 (Reuters) - The U.S. FDA has paused Rocket Pharmaceuticals' (RCKT.O), opens new tab mid-stage gene therapy trial after a patient died from serious complications, the drug developer said on ...
Wall Street Journal29d
The FDA Takes a Trial-Lawyer Turn
The FDA on Tuesday held a panel discussion on the alleged risks of talcum powder. Talc, an anti-caking agent that is mined from rock, is prevalent in food and pharmaceutical products. Plaintiff ...
Healio29d
FDA clears phase 2 trial of immunoglobulin eye drops in dry eye disease
Perspective from Jade Coats, OD, FAAO The FDA cleared an investigational new drug application for a phase 2 trial of GRF312 ophthalmic solution, an immunoglobulin eye drop for the treatment of dry ...
Black Enterprise29d
FDA Plans To Limit COVID Vaccine To Elderly And The High-Risk
A rubber-stamping approach to approving COVID boosters perpetuity without updated clinical trial data under the Biden administration is now over.” The anticipated new guidance from the FDA comes ...
Benzinga.com23d
Rocket Pharma Reports Patient Death In Rare Disease Gene Therapy Trial, FDA Puts Clinical Hold
The FDA placed a clinical hold on the trial for further evaluation. While the clinical hold remains in place, the company is unable to provide guidance on the anticipated completion date of the ...
FierceBiotech22d
Daiichi, Merck pull HER3-DXd filing at FDA after confirmatory trial misses survival endpoint
When Merck & Co. and Daiichi Sankyo last year received an FDA complete response letter for ... results from the phase 3 HERTHENA-Lung02 trial, the results of which are being presented this coming ...
New York Post28d
FDA cracking down on Ozempic copycats, potentially slimming options for consumers
Compounding pharmacies had been producing these off-brand versions under special allowances due to shortages of the FDA-approved medications. Since the FDA declared the shortages over, these ...
CBS News29d
FDA expands COVID vaccine warning about heart side effect risk for young males
Orders to expand the warnings were posted Wednesday by the FDA, in letters dated April 17 to Pfizer and BioNTech about their Comirnaty vaccine and Moderna about its Spikevax vaccine. Both vaccines ...
Becker's Hospital Review23d
Gene therapy trial reports patient death, FDA enacts clinical hold
The company voluntarily paused further dosing in the 12-person trial before the FDA placed a clinical hold on May 23. Since then, the patient died after an acute systemic infection, according to a ...
wsbt22d
More trial runs expected for new COVID-19 vaccines amidst FDA changes
We're taking a closer look at the new FDA regulation of COVID vaccines. We brought this to you yesterday reporting that updated COVID vaccines are no longer recommended for healthier adults and ...
USA Today29d
Feeling itchy? FDA warns about rare side effect from some allergy drugs
The FDA said in a safety warning issued on May 16 that some patients who have taken oral allergy medicines daily for long periods of time — at least a few months but often several years — have ...