FDA
The latest news about FDA: headlines, AI summaries and the full story from every source.
- US FDA Shelves Fast-Track Priority Voucher Pilot Program
- Enliven and FDA Agree on Phase 3 Trial Design for Relcobatinib in Chronic Myeloid Leukemia
- Royalty Pharma Stock as a Diversified Alternative to Revolution Medicines
- FDA Commissioner Nominee Avoids Addressing Trump's Medical Claims in Hearing
- FDA advisory panel endorses GRAIL's Galleri as multi-cancer early detection blood test
- GRAIL Shares Rise on Positive FDA Evaluation of Galleri Cancer Test
- Teva Submits $125 Million Bid for BioXcel Assets Amid Bankruptcy
- Class Action Lawsuit Filed Against Capricor Therapeutics Over FDA BLA Issues
- A Gene Therapy Could Help a Child with Batten Disease — But Access Remains Elusive
- FDA Investigates Salmonella Outbreak Linked to Broccoli Sprouts
- Altria Sues FDA Over Tobacco Product Review Delays
- Altria Sues FDA Over Slow Approval Process for Tobacco Products
- SEC and FDA Sign Memorandum of Understanding
- HHS Plans New Deputy Commissioner Roles at FDA Focused on Technology and Drugs
- Trump Nominates Heidi Overton to Lead FDA
- Outlook Therapeutics Gets FDA Approval for LYTENAVA in Wet AMD Treatment
- uniQure Reports GAAP EPS of -$1.22, Revenue Beats Estimates
- Cyclospora Outbreak Linked to Shredded Iceberg Lettuce Expands to Nine U.S. States
- Cyclospora Outbreak Challenges RFK Jr.'s Food Safety Overhaul and CDC Trust-Building Efforts
- Johnson & Johnson Receives FDA Approval for New Robotic Surgical System
- FDA Reconstitutes Key Peripheral and Central Nervous System Drugs Advisory Committee
- RFK Jr. States Cyclospora Outbreak Is 'Under Control'
- FDA Reverses Part of Cyclosporiasis Investigation but Maintains Link to Taylor Farms Lettuce
- FDA Revises Taylor Farms Cyclospora Test Result to False Positive
- Mineralys Insider Realizes $557K Options Gain Ahead of December FDA Date
- Revolution Medicines Surges on Regulatory Progress and Backing from Stanley Druckenmiller
- Immunome Insider Sells Shares Ahead of FDA Milestone
- Amgen Faces Regulatory Challenges but Dividend Appears Secure
- Merck Expands Kidney Cancer Treatment with FDA Approval of KEYTRUDA and WELIREG Combination
- Armata Pharmaceuticals Receives FDA Fast Track Designation for AP-SA02
- Alvotech Shares Rise After FDA Accepts Entyvio Biosimilar Application for Review
- Grail Stock Faces Volatility After NHS Trial Results Miss Expectations
- Investor Alert: Pomerantz Law Firm Investigates Replimune Group for Potential Securities Fraud
- ImmunityBio Stock Rises on FDA Acceptance of Supplemental BLA for Anktiva
- FDA Announces Leadership Changes for Drug and Biologics Regulators
- Dr. Marty Makary Resigns as FDA Commissioner Amid Internal and External Criticism
- Scholar Rock Announces FDA Acceptance of Apitegromab BLA and Financial Update
- Taysha (TSHA) Q1 2026 Earnings Report and Key Financial Highlights
- Pomerantz Law Firm Investigates Replimune Group for Potential Securities Fraud
- Revolution (RVMD) Q1 2026 Earnings Transcript Summary
- Viridian Therapeutics Approaches PDUFA Decision for Veligrotug in Thyroid Eye Disease
- Eli Lilly Stock Reacts to FDA Liver Failure Report for Foundayo
- FDA Approves First Fruit-Flavored E-Cigarettes for Adults, Marking Policy Shift
- FDA Withholds Studies on Safety of Covid and Shingles Vaccines
- FDA Commissioner Defends Drug Approval Decisions Amid Backlash
- Eli Lilly's Volatile Trading Day Amid FDA Safety Concerns and Market Uncertainty
- Pfizer (PFE) Receives FDA Priority Review for Expanded Use of PADCEV in Bladder Cancer Treatment
- Amgen Reports 4% Sales Growth in Q1 and Submits Label Update for Autoimmune Drug
- AstraZeneca Receives FDA AdCom Recommendation for Truqap in Prostate Cancer Treatment
- Pomerantz Law Firm Investigates Replimune Group, Inc. for Potential Securities Fraud