Health ❯ Pharmaceuticals ❯ Drug Approval

FDA

Clinical Trials Leucovorin Weight Loss Medications Donanemab Kisunla Public Health Nonaddictive Pain Medication Market Reaction Inluriyo UZEDY (risperidone) Expedited Reviews Fast-Track Programs Leadership Issues Leucovorin Calcium Augmentin XR Safety Reviews Ethics NEREUS™ Daraxonrasib CNPV Program Biologics Expanded Access Mifepristone Peptides

3 ARTICLES

4w ago

Judge Pauses Texas-Florida Mifepristone Lawsuit Pending FDA Review

The court-ordered hold gives the Food and Drug Administration time to complete a retrospective safety review that could determine whether the drug stays on the market nationwide.

9 ARTICLES

4w ago

FDA Approves First Broad RAS Inhibitor for Metastatic Pancreatic Cancer

10 ARTICLES

4w ago

FDA Approves Mounjaro to Lower Heart‑Attack and Stroke Risk in High‑Risk Type 2 Diabetes

12 ARTICLES

2mo ago

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

7 ARTICLES

4mo ago

FDA Opens Early Access to KRAS-Targeting Pancreatic Cancer Pill After Strong Survival Data

5 ARTICLES

6mo ago

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

6 ARTICLES

8mo ago

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

9 ARTICLES

9mo ago

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

10 ARTICLES

9mo ago

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

4 ARTICLES

9mo ago

FDA Fast-Tracks Augmentin XR in First Approval Under National Priority Voucher Pilot

3 ARTICLES

10mo ago

Yale Study Finds Only 24% of Medicines Tested Reach Trial-Host Countries Within Five Years

18 ARTICLES

11mo ago

FDA Drug-Review Chief George Tidmarsh Resigns as HHS Probes Conduct

8 ARTICLES

11mo ago

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions

3 ARTICLES

11mo ago

FDA Clears Monthly Uzedy Injection for Maintenance Treatment of Bipolar I Disorder

4 ARTICLES

last yr.

Lilly Steps Up Obesity Push With San Diego Innovation Hub and $6.5 Billion Houston Factory

12 ARTICLES

last yr.

FDA Moves to List Leucovorin for Cerebral Folate Deficiency After White House Autism Promotion

FDA

Judge Pauses Texas-Florida Mifepristone Lawsuit Pending FDA Review

FDA Approves First Broad RAS Inhibitor for Metastatic Pancreatic Cancer

FDA Approves Mounjaro to Lower Heart‑Attack and Stroke Risk in High‑Risk Type 2 Diabetes

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

FDA Opens Early Access to KRAS-Targeting Pancreatic Cancer Pill After Strong Survival Data

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

FDA Fast-Tracks Augmentin XR in First Approval Under National Priority Voucher Pilot

Never miss stories about

FDA

Yale Study Finds Only 24% of Medicines Tested Reach Trial-Host Countries Within Five Years

FDA Drug-Review Chief George Tidmarsh Resigns as HHS Probes Conduct

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions

FDA Clears Monthly Uzedy Injection for Maintenance Treatment of Bipolar I Disorder

Lilly Steps Up Obesity Push With San Diego Innovation Hub and $6.5 Billion Houston Factory

FDA Moves to List Leucovorin for Cerebral Folate Deficiency After White House Autism Promotion

Never miss stories about

FDA