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Drug Approval Process

Mifepristone Compounding Regulations Public Health Mifepristone Regulation Mifepristone Regulations Clinical Trials Medication Safety Biologics License Application Mifepristone Review Over-the-Counter Drugs

6 ARTICLES

3d ago

Lilly Sues Six U.S. Sellers Over Black‑Market Retatrutide

The drugmaker asked platforms, payment firms and regulators to cut off the channels that let unapproved and potentially unsafe products reach consumers.

8 ARTICLES

2w ago

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

20 ARTICLES

5mo ago

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

6 ARTICLES

5mo ago

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

5 ARTICLES

5mo ago

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

5 ARTICLES

7mo ago

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

3 ARTICLES

8mo ago

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

8 ARTICLES

8mo ago

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

20 ARTICLES

8mo ago

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

6 ARTICLES

8mo ago

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

6 ARTICLES

8mo ago

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

13 ARTICLES

8mo ago

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

Drug Approval Process

Lilly Sues Six U.S. Sellers Over Black‑Market Retatrutide

FDA Advisory Panel Narrowly Backs Compounding of Six Unapproved Peptides

FDA Asks Indian Drugmakers to Supply Ifosfamide for US Cancer Shortage

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

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

Never miss stories about

Drug Approval Process

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

Never miss stories about

Drug Approval Process