Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Consumer, Health Professional, Pulmonology March 14, 2025 — FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These products are marketed as both unflavored and flavored nitrous oxide…
- Audience: Pharmacy, Health Care Professional March 13, 2025 — Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is…
- Audience: Consumer, Pharmacy March 11, 2025 — FDA is alerting the public and industry to the results of new agency testing of 95 acne products containing benzoyl peroxide for possible benzene contamination. FDA has concluded that a limited number…
- Audience: Patient, Health Professional, Pharmacy, Immunology March 10, 2025 — As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the…
- Audience: Consumer Benton, Arkansas – 03/03/2025 –One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which…
New Drug Approvals
- COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of Jynneos® (Smallpox and Mpox Vaccine, Live, Non-replicating)…
- Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric…
- On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for…
- Basel, March 28, 2025 – Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic…
- LAKE ZURICH, Ill., March 27, 2025 — Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilar Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug…
New Drug Applications
- WASHINGTON, March 31, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of…
- PRINCETON, N.J. and TOKYO, JAPAN March 31, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a Biologics License Application (BLA) with the U.S…
- MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug…
- CAMBRIDGE, Mass.–(BUSINESS WIRE)–Mar. 25, 2025– Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases…
- Paris, March 25, 2025. The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability…
Clinical Trial Results
- April 1, 2025 — A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness in patients with metastatic gastrointestinal cancers, according to…
- REDWOOD CITY, Calif.–(BUSINESS WIRE)–Mar. 31, 2025– Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and…
- 31 March 2025 — Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care statin…
- INDIANAPOLIS, March 30, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced positive Phase 2 results for lepodisiran, an investigational small interfering RNA (siRNA) therapy designed to lower the production of lipoprotein(a)…
- RAHWAY, N.J.–(BUSINESS WIRE) March 27, 2025 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous…
Daily Med News
- TUESDAY, April 1, 2025 — The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency announced Friday.Women with…
- TUESDAY, April 1, 2025 — Hundreds of U.S. research projects aimed at boosting vaccine confidence have been shut down — just as preventable diseases like measles and flu are on the rise. Since Jan. 20, the U.S. Department of Health and Human…
- TUESDAY, April 1, 2025 — For nearly two decades, a stroke had left a woman unable to speak — until now. Thanks to a new brain implant, her thoughts are being turned into real-time speech, giving her a voice again for the first time in 18…
- TUESDAY, April 1, 2025 — A major round of job cuts at the National Institute for Occupational Safety and Health (NIOSH) could weaken efforts to protect American workers, according to federal health officials. About two-thirds of NIOSH staff –…
- TUESDAY, April 1, 2025 — The number of Americans taking cutting-edge weight-loss drugs like Ozempic, Wegovy and Zepbound has skyrocketed in recent years, a new study says. The number of people without diabetes taking a GLP-1 drug more than tripled…
News for Health Professionals
- TUESDAY, April 1, 2025 — Some commonly prescribed photosensitizing drugs increase skin cancer risk, according to a study published online March 18 in Photodermatology, Photoimmunology & Photomedicine.Gustav Boelsgaard Christensen, from Skåne…
- TUESDAY, April 1, 2025 — For patients with prostate cancer, isodose and dose-escalated moderately hypofractionated radiotherapy (MHFRT) have similar efficacy as conventionally fractionated radiotherapy (CFRT), but bowel toxicity is seen in…
- TUESDAY, April 1, 2025 — An artificial intelligence (AI) approach identified total parenteral nutrition (TPN) formulas that increase safety and potentially reduce costs for neonates admitted to neonatal intensive care units, according to a study…
- TUESDAY, April 1, 2025 — Subclinical cardiac dysfunction is associated with brain imaging markers of neurodegeneration, according to a study published online March 26 in Neurology. Amber Yaqub, from Erasmus MC in Rotterdam, the Netherlands, and…
- TUESDAY, April 1, 2025 — More than 3.8 million U.S. lung cancer deaths were averted during 1970 to 2022, and more than 76 million person-years of life were gained, according to a study published online March 25 in CA: A Cancer Journal for…
