Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Healthcare Provider, Pharmacy, Consumer November 20, 2024 — MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA…
- Audience: Healthcare Provider, Pharmacy, Consumer November 19, 2024 — Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of…
- Audience: Consumers November 4, 2024 – Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level…
- Audience: Consumers November 4, 2024 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The…
- FDA Warns Patients and Health Care Professionals Not to Use Compounded Drugs from Fullerton WellnessAudience: Patients, Health Care Professionals November 1, 2024 — FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical…
New Drug Approvals
- DUBLIN, Nov. 20, 2024 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the…
- Brussels (Belgium), November 20, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults…
- WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ — Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj (revumenib) as the first and only menin inhibitor for the treatment of…
- WOBURN, Mass. Nov 14, 2024 – Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly…
- WARREN, N.J., Nov. 13, 2024 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy…
New Drug Applications
- PASADENA, Calif.–(BUSINESS WIRE)–Nov. 18, 2024– Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational…
- LEXINGTON, Mass.–(BUSINESS WIRE)–Nov. 18, 2024– Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical…
- CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of its Biologics License Application (BLA) for…
- 12 November 2024 — AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or…
- LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”)…
Clinical Trial Results
- BRUSSELS, Belgium and CAMBRIDGE, Mass. – November 19, 2024 – UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel…
- RAHWAY, N.J. November 19, 2024 — Merck, known as MSD outside of the United States and Canada, today announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous…
- PASADENA, Calif., Nov. 19, 2024. Huntington Medical Research Institutes (HMRI), a pioneer in scientific research with a track record of groundbreaking discoveries, announced promising breakthroughs in the treatment of stroke at the American Heart…
- 19 November 2024 — GSK plc (LSE/NYSE: GSK) today announced positive headline results of GLISTEN, the ongoing global phase III clinical trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in…
- PALO ALTO, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented positive initial…
Daily Med News
- WEDNESDAY, Nov. 20, 2024 — Scientists from around the world are making headway in compiling a Human Cell Atlas — a deep dive into the myriad types of cells in the body and their disparate roles in health and disease. The atlas is not yet…
- WEDNESDAY, Nov. 20, 2024 — Rates of postpartum depression have more than doubled in little over a decade among American women, a new analysis shows. While about 1 in every 10 new moms (9.4%) suffered postpartum depression in 2010, that number rose…
- WEDNESDAY, Nov. 20, 2024 — A child in California has tested positive for bird flu, despite having no known contact with infected animals, state officials reported Tuesday. "California has identified a possible bird flu case in a child in Alameda…
- WEDNESDAY, Nov. 20, 2024 — Parents can't monitor everything their kids watch online, but a set of new guidelines may help young people manage their own viewing habits. "Research consistently shows that video content, and the platforms that host…
- WEDNESDAY, Nov. 20, 2024 — Although the United States has made significant headway in curbing cigarette smoking and secondhand smoke exposure, a new report finds deep divisions remain and they run along predictable fault lines. Disparities in…
News for Health Professionals
- WEDNESDAY, Nov. 20, 2024 — For patients with type 2 diabetes and elevated systolic blood pressure, an intensive-treatment strategy is better than a standard-treatment strategy for incidence of major cardiovascular disease events, according to a…
- WEDNESDAY, Nov. 20, 2024 — High cardiorespiratory fitness (CRF) is associated with better cognitive performance and lower dementia risk, according to a study published online Nov. 19 in the British Journal of Sports Medicine. Shuqi Wang, from the…
- WEDNESDAY, Nov. 20, 2024 — The prevalence of high total cholesterol was 11.3 percent among U.S. adults in August 2021 to August 2023, according to a November data brief published by the National Center for Health Statistics. Margaret D. Carroll…
- WEDNESDAY, Nov. 20, 2024 — Teledermoscopy has high accuracy for detecting skin cancers, according to a research letter published online Nov. 9 in the Journal of the American Academy of Dermatology. Jenne P. Ingrassia, from New York Medical College…
- WEDNESDAY, Nov. 20, 2024 — Spinal cord stimulation (SCS) for treatment of chronic pain in the back and/or lower extremities is associated with greater improvements in pain compared with conventional medical management (CMM), according to a review…
