Regulatory Affairs

FDA FDA Approval Drug Approval FDA Approvals Drug Approval Process FDA Approval Process FDA Designations Drug Regulation FDA Regulations Drug Safety

3 ARTICLES

6d ago

Fulcrum to Merge With Slate Medicines and Rebrand After FDA Safety Flags

The all‑stock deal and a $245 million financing give the combined company a new lead migraine antibody and the cash to advance it through mid‑stage trials.

4 ARTICLES

3w ago

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

4 ARTICLES

last mo.

Dr Reddy’s Delays Semaglutide Supply After API-Linked Batches Fail Specs

6 ARTICLES

2mo ago

EMS’s Ozivy Cleared by Anvisa as First Synthetic Semaglutide Pen After Patent Expiry

4 ARTICLES

2mo ago

Brazil Clears First Domestic Semaglutide Pen and Sets Price Ceiling Equal to Ozempic

3 ARTICLES

3mo ago

Theriva’s VCN-01 Extends Survival in Phase 2b Pancreatic Cancer Trial, Paving Way to Phase 3

3 ARTICLES

4mo ago

Peptide Craze Grows as HHS Chief Backs Wider Access

3 ARTICLES

5mo ago

Novo Nordisk Strikes Hims & Hers Deal for Ozempic and Wegovy, Drops Patent Suit

3 ARTICLES

6mo ago

India Orders New Safety Warnings for Doxycycline and Carbimazole

3 ARTICLES

6mo ago

FDA Rejects Moderna’s U.S. Filing for mRNA Flu Shot Over Trial Design

4 ARTICLES

6mo ago

FDA Recalls Specific FreeStyle Libre 3 Sensors Over Faulty Low-Glucose Readings

4 ARTICLES

6mo ago

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

4 ARTICLES

8mo ago

Daré Bioscience Launches Topical Sildenafil Cream for Female Arousal

4 ARTICLES

8mo ago

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

4 ARTICLES

8mo ago

Bristol Myers Delays ADEPT-2 Alzheimer’s Psychosis Readout to 2026 After Site Irregularities

7 ARTICLES

9mo ago

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

3 ARTICLES

9mo ago

Agios’ Sickle Cell Pill Lifts Hemoglobin but Misses Pain-Crisis Goal in Phase 3

Regulatory Affairs

Fulcrum to Merge With Slate Medicines and Rebrand After FDA Safety Flags

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

Dr Reddy’s Delays Semaglutide Supply After API-Linked Batches Fail Specs

EMS’s Ozivy Cleared by Anvisa as First Synthetic Semaglutide Pen After Patent Expiry

Brazil Clears First Domestic Semaglutide Pen and Sets Price Ceiling Equal to Ozempic

Aidoc Raises $150 Million to Scale FDA-Cleared Imaging AI Platform

Gilead Closes $7.8 Billion Arcellx Deal to Take Full Control of Anito‑cel

Clearmind’s AUD Candidate Meets Early Safety Goal as Shares Double

Theriva’s VCN-01 Extends Survival in Phase 2b Pancreatic Cancer Trial, Paving Way to Phase 3

Peptide Craze Grows as HHS Chief Backs Wider Access

Never miss stories about

Regulatory Affairs

Novo Nordisk Strikes Hims & Hers Deal for Ozempic and Wegovy, Drops Patent Suit

India Orders New Safety Warnings for Doxycycline and Carbimazole

FDA Rejects Moderna’s U.S. Filing for mRNA Flu Shot Over Trial Design

FDA Recalls Specific FreeStyle Libre 3 Sensors Over Faulty Low-Glucose Readings

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

Daré Bioscience Launches Topical Sildenafil Cream for Female Arousal

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

Bristol Myers Delays ADEPT-2 Alzheimer’s Psychosis Readout to 2026 After Site Irregularities

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

Agios’ Sickle Cell Pill Lifts Hemoglobin but Misses Pain-Crisis Goal in Phase 3

Never miss stories about

Regulatory Affairs