News

Threat in your medicine cabinet: The FDA’s gamble on America’s drugs
The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to ...
FDA Approves First Twice-a-Year HIV Prevention Shot
FRIDAY, June 20, 2025 (HealthDay News) — A new shot to prevent HIV infection has just been approved — and it only needs to be ...
Sanofi, Regeneron Get FDA Approval for Dupixent to Treat Rare Skin Disease
The Food and Drug Administration approved the drug for adult patients with bullous pemphigoid, which mainly affects the ...
STAT2d
Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...
FDA Approves Once-Monthly Andembry for Hereditary Angioedema
By Lori Solomon HealthDay ReporterFRIDAY, June 20, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
FDA approves new twice-yearly HIV shot. What to know
The FDA approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show ...
FDA announces sweeping changes to speed up the drug review process
An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...
STAT2d
As AI device market grows, FDA’s accounting goes silent
As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.
Ginger Beer Recall Update as FDA Issues Highest Risk Warning
Rachel's Ginger Beer issued a voluntary recall for its "Cucumber x Tarragon Ginger Beer" in November last year due to ...
FDA approves twice-a-year injection for HIV prevention
A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug ...
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Trump FDA Chief Reportedly Makes End Run Around Career Bureaucrats
Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...