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Drug Approval Process

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Supreme Court Blocks 5th Circuit, Keeps Abortion Pill Mail Access for Now

The stay preserves remote dispensing during Louisiana’s appeal.

Supreme Court Weighs Mifepristone Mail Access as Temporary Stay Nears Deadline

FDA Proposes Blocking Bulk Compounding of GLP-1 Drugs by Outsourcing Facilities

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

FDA Poised to Ease Compounding Ban on Dozen-Plus Peptides

Investor Class Actions Target Atara Over FDA Setbacks to EBVALLO

Plaintiff Firms Step Up uniQure Solicitation After FDA Rebuke, With April 13 Lead-Plaintiff Deadline

Hawley Seeks to Revoke FDA Approval of Abortion Pill Mifepristone With New Senate Bill

FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

Compass Pathways’ Psilocybin Therapy Hits Phase 3 Goal in Treatment-Resistant Depression

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

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