Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Health Care Professional, Consumer FDA Drug Safety Communication – September 1, 2026 What Is FDA Doing? The Food and Drug Administration has approved revisions to the labeling for ferric carboxymaltose injection (currently marketed…
- Audience: Health Care Professional, Consumer DEERFIELD, Ill., August 25, 2026 — Baxter International Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of particulate matter identified…
- Audience: Health Care Professional, Consumer DEERFIELD, Ill., August 25, 2026 — Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of 70% Dextrose Injection due to the potential presence of particulate matter identified as…
- Audience: Health Care Professional, Consumer DEERFIELD, Ill., August 25, 2026 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter…
- Audience: Health Care Professional, Consumer AUBURN, Ala. (August 21, 2026) – Vitruvias Therapeutics Inc. is voluntarily recalling one lot (Lot. No. 504950) of Thyroid Tablets, USP 30 mg to the consumer level. The product is being recalled…
New Drug Approvals
- September 03, 2026 — The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease…
- BURLINGTON, Mass.–(BUSINESS WIRE)–August 31, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446) today announced the U.S. Food and Drug Administration (FDA) has approved BESREMi® (ropeginterferon…
- OSAKA, Japan and CAMBRIDGE, Massachusetts, August 28, 2026 – Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for Mimrylo (rusfertide) for the treatment of erythrocytosis…
- FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR)…
- August 28, 2026 — The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. On April 15, 2026…
New Drug Applications
- SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug…
- SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE) August 24, 2026 — United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the FDA has accepted the New Drug Application (NDA) for…
- August 19, 2026 — The FDA’s Complete Response Letter relates to the previously communicated observations at NerPharMa, concerning outstanding GMP (Good Manufacturing Practice) observations, as well as a request for additional commercial…
- PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 19, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) accepted…
- SAN DIEGO, Aug. 11, 2026 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative…
Clinical Trial Results
- NORTH CHICAGO, Ill., Sept. 3, 2026 /PRNewswire/ — AbbVie (NYSE: ABBV) announced positive topline results from the Phase 3 CERVINO study1 evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available…
- NOVATO, Calif., September 2, 2026 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced results from the Phase 3 Aspire study for apazunersen (GTX-102) in Angelman syndrome. The study did not achieve the primary…
- TEL AVIV, Israel, September 2, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from an ongoing Phase 2a study of TEV ‘408, an investigational anti-interleukin-15…
- Basel, September 1, 2026 – Novartis today announced positive topline results from its Phase III REMODEL-1/-2 trials of remibrutinib in relapsing multiple sclerosis.1 Remibrutinib, a highly selective and potent oral Bruton’s tyrosine…
- BEDMINSTER, N.J., Sept. 01, 2026 (GLOBE NEWSWIRE) — Juniper Biosciences today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to JBS-003 (18F-fluoromisonidazole, or FMISO), the…
Daily Med News
- FRIDAY, Sept. 4, 2026 — Your teen has been flipping through Instagram for nearly an hour when they get a pop-up that says: “SURGEON GENERAL’S WARNING: Social media is associated with significant mental health harms for children…
- FRIDAY, Sept. 4, 2026 — A frozen berry blend sold at Walmart stores in 16 states has been pulled from shelves as a precaution, widening a recall connected to an ongoing E. coli outbreak. Frutas y Hortalizas del Sur S.A., a produce supplier…
- FRIDAY, Sept. 4, 2026 — Heart-pumping aerobic exercise can boost key thinking skills among women after menopause, a new study says. Postmenopausal women who practiced aerobic exercise four days a week for half a year performed better on…
- FRIDAY, Sept. 4, 2026 — Your smartwatch may be giving you more credit for your workout than you actually earned. Researchers had 58 adults complete a cycling workout wearing four popular smartwatches, then compared their calorie estimates…
- FRIDAY, Sept. 4, 2026 — There’s one personal factor that boosts survival among seniors who undergo surgery to repair a broken hip. Not how much money they have. Not where they live. Not whether they recuperated at home or in a nursing…
News for Health Professionals
- FRIDAY, Sept. 4, 2026 — The evidence is insufficient to support routine use of lumbar supports for managing chronic low back pain (CLBP) in adults, according to research published online Sept. 2 in the Cochrane Database of Systematic…
- FRIDAY, Sept. 4, 2026 — Illicit-source fentanyl exposure is linked to a significantly higher risk of opioid-related harmful outcomes than medical-source exposure, according to a study published online Aug. 14 in eClinicalMedicine.Seungyeon Lee…
- FRIDAY, Sept. 4, 2026 — For patients with atrial fibrillation (AF) and Alzheimer disease (AD), non-vitamin K oral anticoagulants (NOACs) are associated with modestly slower cognitive decline, according to a study published online Aug. 12 in the…
- FRIDAY, Sept. 4, 2026 — For patients with prostate cancer, adverse pathological features are prognostic, but do not modify the benefit of adding hormone therapy (HT) to postoperative radiotherapy, according to a study published online July 28 in…
- FRIDAY, Sept. 4, 2026 — Individuals with severe mental illness (SMI) have increased odds ratios for dementia and ischemic stroke, even at younger ages, according to a study published in the September issue of European…
