Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Consumer June 06, 2025 — Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level…
- Audience: Consumer, Pharmacy, Health Care Professional June 02, 2025 — Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on…
- Audience: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology May 23, 2025 — The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare…
- Audience: Consumer May 21 2025, Nogales, AZ, Umary USA is voluntarily recalling all lots of Unavy Ácido Hialurónico (30 caplets/850 mg) and Umovy Ácido Hialurónico (30 caplets/850 mg), to the consumer level. FDA…
- Audience: Health Care Professionals, Consumers May 16, 2025 — FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names). Can occur…
New Drug Approvals
- Berlin, June 3, 2025 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for use in…
- 02 June 2025 — Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved…
- CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and…
- GENEVA–(BUSINESS WIRE) May 28, 2025 — Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the U.S. Food and Drug Administration (FDA) has approved Tryptyr® (acoltremon ophthalmic…
- DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare…
New Drug Applications
- SAN DIEGO and TOKYO, June 01, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the U.S. Food and Drug Administration (FDA) has accepted…
- NEEDHAM, Mass., May 29, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel…
- Tokyo and Basking Ridge, NJ – May 29, 2025 – The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck & Co., Inc, Rahway, N.J., USA’s patritumab deruxtecan…
- PRINCETON, N.J. and TOKYO, JAPAN May 27, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has accepted for review…
- NEW HAVEN, Conn., May 14, 2025 /PRNewswire/ — Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the Company that they are extending the PDUFA date for…
Clinical Trial Results
- FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the…
- Redwood City, Calif., June 3, 2025 – Pheast Therapeutics, a clinical-stage biotechnology company developing novel therapies to unleash the power of macrophages on aggressive, difficult-to-treat cancers, today announced that the U.S. Food and…
- LEXINGTON, Mass. and AMSTERDAM, June 02, 2025 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today provided a regulatory update on AMT-130…
- CAMBRIDGE, Mass.–(BUSINESS WIRE) June 03, 2025 — Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to…
- Paris, June 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation, to target a…
Daily Med News
- SUNDAY, June 8, 2025 — Why does your cat purr when you pet it — or meow when dinner’s late? A new study from the Wildlife Research Center at Kyoto University in Japan suggests the answer could be in its genes. Researchers looked…
- SATURDAY, June 7, 2025 — You're not just getting older, you're probably getting bigger. Between their 20s and 40s, most Americans can expect to put on 10 to 25 pounds — and after 30, exercise may not have the same payoff it once did…
- FRIDAY, June 6, 2025 — The U.S. Food and Drug Administration has granted de novo authorization to CLAIRITY BREAST, a first-in-class, image-based platform that can help predict a woman's risk for breast cancer. CLAIRITY BREAST is designed as a…
- FRIDAY, June 6, 2025 — Attorneys general from four states are asking the U.S. Food and Drug Administration (FDA) to lift restrictions on mifepristone, a pill used in medication abortions. The request came Thursday from top officials in…
- FRIDAY, June 6, 2025 — A new injection to prevent HIV is expected to be approved by the U.S. Food and Drug Administration (FDA) later this month. If approved, the shot — lenacapavir — would be given twice a year and could be a big…
News for Health Professionals
- FRIDAY, June 6, 2025 — For patients undergoing noncardiac surgery, neurocognitive outcomes do not differ with hypotension-avoidance and hypertension-avoidance strategies, according to a study published online June 3 in the Annals of Internal…
- FRIDAY, June 6, 2025 — Experienced weight stigma (EWS) improves from pre- to post-metabolic bariatric surgery (MBS), according to a study published online June 5 in Health Psychology. Larissa A. McGarrity, Ph.D., from the University of Utah in…
- FRIDAY, June 6, 2025 — For patients with metabolic dysfunction-associated steatohepatitis (MASH), treatment with dapagliflozin is beneficial for improvement of MASH without worsening of fibrosis and for improvement of fibrosis without worsening of…
- FRIDAY, June 6, 2025 — Body mass index (BMI) and physical activity are associated with the risk for subsequent neoplasms among childhood cancer survivors, according to a study published online June 5 in JAMA Oncology. Lenat Joffe, M.D., from…
- FRIDAY, June 6, 2025 — For pediatric patients presenting to a hospital, caregiver concern for clinical deterioration is associated with critical illness, according to a study published online May 29 in The Lancet Child and Adolescent Health. Erin…
