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FDA

Drug Approval Process Vaccine Approval Process Drug Safety New Drug Application Drug Approval Biologics License Application Drug Recalls Drug Approval Processes Product Recalls Fast Track Designation

6 ARTICLES

5d ago

FDA Scientists Find Little Evidence to Support Compounding of Popular Peptides

Staff briefings plus a reconstituted advisory panel dominated by clinicians with industry ties set the stage for a July meeting that could shape whether compounding pharmacies may make these products

4 ARTICLES

5d ago

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

3 ARTICLES

5d ago

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

6 ARTICLES

2w ago

FDA Panel Weighs Moderna’s Bid for First U.S. mRNA Flu Vaccine

6 ARTICLES

2w ago

More Than 370,000 Duloxetine Bottles Recalled Over Nitrosamine Contamination

3 ARTICLES

2w ago

FDA Clears Dexcom Stelo as First OTC CGM for Children

3 ARTICLES

3w ago

FDA Clears Dexcom Stelo Over‑the‑Counter Glucose Monitor for Children Ages 2 and Up

3 ARTICLES

3w ago

Novartis Says Del‑brax Study Met Endpoints and Reinforced Phase 3 Dosing

5 ARTICLES

4w ago

Fulcrum Halts Pociredir Development After FDA Flags PRC2 Cancer Risk

4 ARTICLES

last mo.

FDA Extends Review of AstraZeneca’s Camizestrant

4 ARTICLES

last mo.

Apnimed Pill Cuts Sleep Apnea Events in Phase 3 as Company Seeks FDA Approval

4 ARTICLES

last mo.

FDA Places Full Clinical Hold on Aardvark’s ARD-101 Prader–Willi Trials

4 ARTICLES

last mo.

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

7 ARTICLES

2mo ago

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

13 ARTICLES

2mo ago

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

6 ARTICLES

2mo ago

Moderna Beats Q1 Forecast as Overseas COVID Shot Sales Rebound

9 ARTICLES

2mo ago

FDA Launches First Real-Time Clinical Trial Pilot With AstraZeneca and Amgen

FDA

FDA Scientists Find Little Evidence to Support Compounding of Popular Peptides

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

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

FDA Panel Weighs Moderna’s Bid for First U.S. mRNA Flu Vaccine

More Than 370,000 Duloxetine Bottles Recalled Over Nitrosamine Contamination

FDA Clears Dexcom Stelo as First OTC CGM for Children

FDA Clears Dexcom Stelo Over‑the‑Counter Glucose Monitor for Children Ages 2 and Up

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FDA

Novartis Says Del‑brax Study Met Endpoints and Reinforced Phase 3 Dosing

Fulcrum Halts Pociredir Development After FDA Flags PRC2 Cancer Risk

FDA Extends Review of AstraZeneca’s Camizestrant

Apnimed Pill Cuts Sleep Apnea Events in Phase 3 as Company Seeks FDA Approval

FDA Places Full Clinical Hold on Aardvark’s ARD-101 Prader–Willi Trials

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

Moderna Beats Q1 Forecast as Overseas COVID Shot Sales Rebound

FDA Launches First Real-Time Clinical Trial Pilot With AstraZeneca and Amgen

Never miss stories about

FDA