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Drug Approval

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EU Drug Panel Backs Sanofi’s Cenrifki for Non‑Relapsing SPMS

The move sets up a final EU ruling that may give people with progressive MS a needed way to slow disability.

Novo Nordisk’s Oral Semaglutide Meets Goal in Teen Type 2 Diabetes Trial

HHS Chief Distances From FDA Replimune Denial as Oncologists Dispute Review

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

Health Canada Approves Neffy, First Nasal Epinephrine for Anaphylaxis

Acoramidis Shows Durable Survival Benefit in ATTR-CM Through 54 Months

FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

Anvisa Authorizes Multidose Mounjaro Pen for Brazil

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

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