DrugApproval

FDA Commissioner Marty Makary's Shock Departure Jolts Washington

The Unfolding Saga: Inside the FDA's Scrutiny of the Abortion Pill

A Critical Voice Departs: Dr. Vinay Prasad's Resignation From FDA Advisory Role

The FDA's Risky Gamble: Incentivizing Speed in Drug Approvals

Savara Shares Soar as FDA Grants Priority Review for Rare Lung Disorder Therapy

Unveiling the Truth: Are FDA Drug Studies Truly Robust?

A Glimmer of Hope? Why Wall Street is Bullish on ImmunityBio (IBRX) After Key Saudi Approval

A Regulatory Stumble: FDA Puts Brakes on Moderna's Flu Vaccine Hopes

Summit Therapeutics on the Cusp: A Dual-Action Lung Cancer Drug Faces its Moment of Truth

The FDA's Bold New Vision: Could One Clinical Trial Be Enough for Drug Approval?

A New Chapter for Wockhardt? Chairman 'Very Confident' on Novel Antibiotic's USFDA Acceptance

When Leadership Takes the Reins: Unpacking the FDA's Unusual Priority Voucher Vote

The Unflinching Hand at the Helm: Richard Pazdur's Enduring Legacy at the FDA

The FDA's Tightening Grip: A Crucible for Biotech's Biggest Bets

The Zynity Enigma: When Innovation Meets Intense Scrutiny at the FDA

The Weight of Expectation: FDA, Obesity Drugs, and the Uneasy Dance Between Speed and Safety

A Sweeping Change for Little Smiles: Why the FDA Just Banned Unapproved Fluoride for Kids

Unlocking Affordability: The FDA's Bold Play to Turbocharge Generic Drug Access

The Long Road to Hope: Anavex's Alzheimer's Drug Hits a Regulatory Wall

FDA Unleashes Game-Changing Incentive: Priority Review Vouchers Set to Revolutionize Drug Development

Under Siege: Whistleblowers Unmask Political Pressures Threatening FDA's Scientific Soul

Biohaven's Breakthrough Bid: Navigating FDA Flexibility for Spinocerebellar Ataxia's Future

Biocon Biologics Secures Landmark USFDA Approval for Critical Antibacterial Drug

FDA's Landmark Decision: Mifepristone Secures Full Approval, Reshaping Reproductive Healthcare Landscape

Wockhardt Seeks USFDA Nod for Revolutionary Antibiotic Zaynich: A New Hope Against Superbugs

Historic Shift: FDA Greenlights Generic Abortion Pill, Redefining Access Landscape

Healthcare's Brink: How a Government Shutdown Threatens HHS, CDC, and FDA

Ozempic Arrives in India: A New Dawn for Type 2 Diabetes Management and Weight Loss

MoonLake Immunotherapeutics Skyrockets: Is a Biotech Buyout Imminent After Breakthrough Skin Drug Trial?

Lupin Achieves Major Milestone: USFDA Grants Tentative Approval for Generic HIV Treatment Drug

FDA Greenlights Leucovorin for Cancer Support Amidst Unrelated Autism Treatment Buzz

European Triumph: KalVista and Ionis Celebrate Key Drug Approvals Across the EU

Market Movers: The Stocks Poised for Dynamic Action on September 15th

Controversial Critic Returns: Dr. Vinay Prasad Reassumes Key FDA Role

Game-Changer Alert: Travere Therapeutics Shares SOAR as FDA Fast-Tracks Rare Kidney Disease Drug Sparsentan!

A New Horizon for Lymphoma Patients: InnoCare's HIBRUCA Approved in Singapore for Marginal Zone Lymphoma

The Unprecedented Assault on Mifepristone: How a Lone Judge Ignited a National Firestorm Over Abortion Access

FDA Delivers Crushing Blow to Outlook Therapeutics: Eye Drug Approval for Wet AMD Declined

Kyverna Therapeutics: Charting a Course for Revolutionary Autoimmune CAR T Therapy by 2026