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FDA Approves Langlara as Interchangeable Biosimilar to Lantus

Pharmacy-level substitution could expand access.

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

FDA Grants Orphan Drug Status to Immutep’s Efti for Soft Tissue Sarcoma

CHMP Backs Xolremdi for WHIM Syndrome Under Exceptional Circumstances

Brazil Government Opposes Patent Breaks for Weight-Loss Pens After House Fast-Tracks Bill

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

FDA Seeks Removal of Suicide Warnings From Saxenda, Wegovy and Zepbound

India Rolls Out Drug-Law Compounding, Allowing Minor Breaches to Be Settled With Fines

Zenas' Obexelimab Meets Phase 3 Goals in IgG4-Related Disease With 56% Flare Risk Cut

FDA Adds Brain Tumor Warning to Two Depo‑Provera Injections

Gilead’s BIC/LEN HIV Tablet Matches Biktarvy in Phase 3 Switch Trial

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

USFDA Accepts Wockhardt’s NDA for Novel Antibiotic Zaynich as Stock Rallies

Yale Study Finds Only 24% of Medicines Tested Reach Trial-Host Countries Within Five Years

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions

India Drafts New Drugs, Medical Devices and Cosmetics Law to Give CDSCO Enforcement Powers

Former FDA Biologics Chief Peter Marks Joins Eli Lilly to Lead Infectious Disease and Molecule Discovery

ANMAT Shuts Laboratorios Beta and Pulls Ten Exotran Lots Over Quality Failures

FDA to Publicly Release All Future Drug Rejection Letters, Posts 89 Recent CRLs

FDA Launches Coordinated Pathway to Review Therapies for Ultra-Rare Genetic Diseases