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Drug Approval

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New Study Finds Nearly Fivefold Higher Reported ‘Eye Stroke’ Risk With Wegovy vs Ozempic

A retrospective FDA adverse‑event analysis reported the signal, prompting regulator warnings and calls for prospective studies.

EU Regulators Back First Combined COVID-19 and Flu mRNA Shot for Adults 50 and Over

EMA Panel Backs Conditional EU Approval for Ojemda in Pediatric Low-Grade Glioma

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

Brazil Authorizes First Human Trial of UFRJ’s Polilaminina for Acute Spinal Cord Injury

UK Approves First Twice-Yearly Asthma Biologic as GSK Targets 2026 Launch

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

EMA Panel Backs Higher 7.2 mg Wegovy Dose for Obesity

Minsa Loans Tacrolimus to EsSalud, Citing 45-Day Bridge for About 100 Patients

Bayer’s Asundexian Cuts Recurrent Stroke Risk in Phase III Without More Major Bleeding

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

EMA Panel Backs Higher-Dose Spinraza for 5q SMA

EU Medicines Panel Backs Teizeild to Delay Type 1 Diabetes Onset

India Approves Bayer’s Kerendia for HFpEF and HFmrEF

Fujirebio to Seek Year-End Approval for Japan’s First Alzheimer’s Blood Test

MHRA Unveils Overhaul to Speed Rare-Disease Drug Approvals

Final EMBARK Results Show 40% Lower Mortality With Enzalutamide Plus Leuprolide in High-Risk Recurrent Prostate Cancer

CHMP Backs Scemblix Indication Update for Pretreated Ph+ CML in Chronic Phase

EU Regulators Back Libtayo as Adjuvant Therapy for High-Risk Cutaneous Squamous Cell Carcinoma

Phase 3 Trial Finds Tukysa Improves PFS in First-Line Maintenance for HER2-Positive Metastatic Breast Cancer