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FDA Clears Wearable Injector Form of Sanofi’s Multiple Myeloma Drug

The approval should shorten infusion time for patients and position Sanofi to expand how it delivers cancer therapies.

Ocular Therapeutix Plans Q4 Filing for AXPAXLI After Reported FDA Alignment

CHMP Recommends Adding Oral Wegovy Tablets to EU Approval

FDA Approves Langlara as Interchangeable Biosimilar to Lantus

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

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

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

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

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

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

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

FDA Approves First New Fibromyalgia Treatment in 15 Years

Moderna Withdraws Flu-COVID Vaccine Application After FDA Requests More Data