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Drug Approval Process

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Strive Compounding Sues Lilly and Novo, Alleging Antitrust Push to Block Compounded GLP-1s

The filing spotlights alleged telehealth exclusivity following FDA curbs on semaglutide compounding.

Louisiana Joins Texas, Florida in New Court Moves Targeting FDA Abortion Pill Rules

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS

FDA Proposes Adding Bemotrizinol to U.S. Sunscreens, Invites Public Comment

Novo Nordisk Presses India Expansion and Higher-Dose Push as Analyst Views Diverge

Texas and Florida Sue FDA to Overturn Mifepristone Approvals and Mail-Order Access

Hawley Pressures FDA Chief as Anti‑Abortion Groups Demand Firing Over Reported Mifepristone Review Delay

ACLU Sues FDA to Obtain Records on Mifepristone Review

Cytokinetics Investors Face Nov. 17 Deadline to Seek Lead Role in Aficamten Securities Case

Intellia Pauses Phase 3 Trials of CRISPR Therapy After Severe Liver Event

Kenvue Asks FDA to Reject Autism Warning on Tylenol in Pregnancy

ATyr’s Sarcoidosis Drug Fails Phase 3 Goal, Shares Plunge Over 80%

FDA Creates 'Green List' for GLP-1 Ingredients as WHO Names the Drugs Essential

FDA Warns Five Brands Over Unauthorized Mousse Sunscreens

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy

Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure

FDA Commissioner Pledges Safety Review of Abortion Pill Mifepristone