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FDA

Drug Approval Process Vaccine Approval Process Drug Approval Drug Safety Biologics License Application New Drug Application Drug Recalls Drug Approval Processes Product Recalls Advisory Committees

3 ARTICLES

2w ago

Nearly All FDA-Cleared AI Medical Devices Haven’t Been Tested for Patient Benefit

Researchers say the FDA’s 510(k) clearance route lets many AI tools reach clinical use without proof they change mortality, hospitalizations, or quality of life.

4 ARTICLES

2w ago

Prestige Recalls Nearly 40,000 Clear Eyes Itch-Relief Drops Over Sterility Concerns

10 ARTICLES

3w ago

Amylyx’s Avexitide Cuts Moderate‑to‑Severe Post‑Bariatric Hypoglycemia Events 55% in Phase 3

4 ARTICLES

3w ago

Cold Platelets Stored Up to 21 Days Are Clinically Noninferior in Cardiac Surgery

6 ARTICLES

4w ago

FDA Panel Rejects Deramiocel Cardiac Claim After Lancet Publishes HOPE‑3 Results

4 ARTICLES

last mo.

Dupixent Surge Lets Sanofi Reset Strategy as Regeneron Posts Strong Quarter

4 ARTICLES

last mo.

Major Rugby Recalls 12 Batches of Levothyroxine Nationwide

3 ARTICLES

last mo.

MapLight’s Schizophrenia Candidate Posts Mixed Phase II Results as Shares Plummet

4 ARTICLES

last mo.

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

18 ARTICLES

last mo.

Manufacturer Recalls Generic Zyrtec Over Possible Ranitidine Contamination

3 ARTICLES

last mo.

FDA Grants Priority Review to Pfizer’s Talzenna Plus Xtandi for HRR-Altered mCSPC

8 ARTICLES

2mo ago

FDA Scientists Say Evidence Lacks for Allowing Seven Popular Peptides in Compounding

4 ARTICLES

2mo ago

Regulators Move to Strip Approval of Tavneos After Trial Misconduct and Liver Safety Signals

3 ARTICLES

2mo ago

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

3 ARTICLES

2mo ago

FDA Classifies Chlorthalidone Recall as Class II

10 ARTICLES

2mo ago

Nationwide Recall of 25 mg Chlorthalidone Covers 11,460 Bottles

FDA

Nearly All FDA-Cleared AI Medical Devices Haven’t Been Tested for Patient Benefit

Prestige Recalls Nearly 40,000 Clear Eyes Itch-Relief Drops Over Sterility Concerns

Amylyx’s Avexitide Cuts Moderate‑to‑Severe Post‑Bariatric Hypoglycemia Events 55% in Phase 3

Cold Platelets Stored Up to 21 Days Are Clinically Noninferior in Cardiac Surgery

FDA Approves Orzeyful as First Orexin Agonist for Narcolepsy Type 1

Eli Lilly Opens Limited Early Access to Experimental Obesity Drug Retatrutide

Nearly 12 Million Rohto Eye Drop Cartons Recalled Over Sterility Concerns

FDA Advisers Find Replimune’s RP1 Trial Results Clinically Meaningful

FDA Panel Rejects Deramiocel Cardiac Claim After Lancet Publishes HOPE‑3 Results

Dupixent Surge Lets Sanofi Reset Strategy as Regeneron Posts Strong Quarter

Never miss stories about

FDA

Major Rugby Recalls 12 Batches of Levothyroxine Nationwide

MapLight’s Schizophrenia Candidate Posts Mixed Phase II Results as Shares Plummet

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

Manufacturer Recalls Generic Zyrtec Over Possible Ranitidine Contamination

FDA Grants Priority Review to Pfizer’s Talzenna Plus Xtandi for HRR-Altered mCSPC

FDA Scientists Say Evidence Lacks for Allowing Seven Popular Peptides in Compounding

Regulators Move to Strip Approval of Tavneos After Trial Misconduct and Liver Safety Signals

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

FDA Classifies Chlorthalidone Recall as Class II

Nationwide Recall of 25 mg Chlorthalidone Covers 11,460 Bottles

Never miss stories about

FDA