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Drug Safety

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3 ARTICLES

8h ago

FDA Approves Pirtobrutinib for Frontline Treatment of CLL and SLL

The decision follows randomized trial results showing a large progression‑free survival gain while regulators flagged important safety warnings and said overall survival data remain immature.

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7 ARTICLES

last wk.

FDA Approves Lilly’s Once-Weekly Basal Insulin Onswik for Adults With Type 2 Diabetes

6 ARTICLES

2w ago

FDA Approves Isembyld, First Muscle‑Directed Therapy for Spinal Muscular Atrophy

3 ARTICLES

2w ago

Amylyx’s Avexitide Cuts Moderate‑to‑Severe Post‑Bariatric Hypoglycemia Events 55% in Phase 3

3 ARTICLES

last mo.

Sionna Halts SION-719 After Mid-Stage Cystic Fibrosis Trial Misses Key Biomarker

13 ARTICLES

last mo.

Mounjaro Study Finds Lower Heart‑Attack Risk as UK Safety Reports Rise

5 ARTICLES

2mo ago

ANMAT Publishes New Rule To Speed Changes to Vaccines and Other Biologicals

6 ARTICLES

2mo ago

Biogen's Tau Drug Cuts Brain Tau but Misses Dose‑Response Goal

4 ARTICLES

3mo ago

EMA Committee Recommends Revoking Tavneos Authorization

7 ARTICLES

3mo ago

Definium’s Oral LSD Pill Meets Primary Endpoint in Phase 3 Depression Trial

4 ARTICLES

3mo ago

FDA Grants Accelerated Approval to Sanofi’s Tzield for Children With Stage 3 Type 1 Diabetes

11 ARTICLES

4mo ago

Abivax Drug Shows Breakthrough Ulcerative Colitis Results as Shares Plunge After Cancer Cases

3 ARTICLES

4mo ago

FDA Approves Durvalumab Plus BCG for High‑Risk Non‑Muscle Invasive Bladder Cancer

6 ARTICLES

4mo ago

Rajasthan Bans TOCIN Oxytocin After Sample Shows No Active Ingredient

3 ARTICLES

4mo ago

FDA Clears First Biosimilars to Simponi and Simponi Aria: IMMGOLIS and IMMGOLIS INTRI

3 ARTICLES

4mo ago

Imfinzi With Enfortumab Vedotin Improves Survival in Phase III Bladder Cancer Trial

5 ARTICLES

5mo ago

FDA Clears Dupixent as First Biologic for Young Children With Chronic Spontaneous Urticaria

Drug Safety

FDA Approves Pirtobrutinib for Frontline Treatment of CLL and SLL

FDA Approves Lilly’s Once-Weekly Basal Insulin Onswik for Adults With Type 2 Diabetes

FDA Approves Isembyld, First Muscle‑Directed Therapy for Spinal Muscular Atrophy

AstraZeneca’s Etcamah Falls Short in Pivotal SERENA‑4 Breast Cancer Trial

Aficamten Improves Symptoms and Exercise Capacity in Nonobstructive HCM

FDA Approves Lisraya as First Oral Treatment for Adult Dermatomyositis

Amylyx’s Avexitide Cuts Moderate‑to‑Severe Post‑Bariatric Hypoglycemia Events 55% in Phase 3

Sionna Halts SION-719 After Mid-Stage Cystic Fibrosis Trial Misses Key Biomarker

Mounjaro Study Finds Lower Heart‑Attack Risk as UK Safety Reports Rise

ANMAT Publishes New Rule To Speed Changes to Vaccines and Other Biologicals

Never miss stories about

Drug Safety

Biogen's Tau Drug Cuts Brain Tau but Misses Dose‑Response Goal

EMA Committee Recommends Revoking Tavneos Authorization

Definium’s Oral LSD Pill Meets Primary Endpoint in Phase 3 Depression Trial

FDA Grants Accelerated Approval to Sanofi’s Tzield for Children With Stage 3 Type 1 Diabetes

Abivax Drug Shows Breakthrough Ulcerative Colitis Results as Shares Plunge After Cancer Cases

FDA Approves Durvalumab Plus BCG for High‑Risk Non‑Muscle Invasive Bladder Cancer

Rajasthan Bans TOCIN Oxytocin After Sample Shows No Active Ingredient

FDA Clears First Biosimilars to Simponi and Simponi Aria: IMMGOLIS and IMMGOLIS INTRI

Imfinzi With Enfortumab Vedotin Improves Survival in Phase III Bladder Cancer Trial

FDA Clears Dupixent as First Biologic for Young Children With Chronic Spontaneous Urticaria

Never miss stories about

Drug Safety