Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Healthcare Provider, Pharmacy, Consumer Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for…
- Audience: Health Professional April 18, 2024 — In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell malignancies including chimeric antigen receptor CAR-positive…
- Audience: Health Care Professionals, Consumers April 16, 2024 — FDA is alerting health care professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple states and administered to…
- Audience: Healthcare Provider, Pharmacy, Consumer PRINCETON, N.J. (April 9, 2024) – Otsuka America Pharmaceutical, Inc. (Otsuka) is voluntarily recalling certain Abilify (aripiprazole) Tablets in the United States due to cross-contamination…
- Audience: Consumers April 5, 2024 – Oranjestad, Aruba, Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to…
New Drug Approvals
- April 24, 2024 — Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus…
- BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) — Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing…
- CULVER CITY, Calif., April 22, 2024 — ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus…
- OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Entyvio® (vedolizumab) subcutaneous (SC) administration for…
- NEWTON, Mass.–(BUSINESS WIRE) April 18, 2024 –Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the U.S. Food &…
New Drug Applications
- CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)…
- ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today…
- NEEDHAM, Mass., April 8, 2024 /PRNewswire/ — Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today…
- DUBLIN, April 2, 2024 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking…
- 2 April 2024 — AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor…
Clinical Trial Results
- FORT MYERS, Fla., April 25, 2024. Florida Cancer Specialists & Research Institute, LLC (FCS) medical oncologist and hematologist Ernesto Bustinza-Linares, MD is co-author of a recent abstract published in the American Society of Clinical…
- April 24, 2024 — In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and rare genetic disorder that affects a wide range of bodily systems, leading to…
- Lykos Therapeutics Announces Completion of European Phase 2 Study for MDMA-Assisted Therapy for PTSDSAN JOSE, Calif., April 24, 2024. Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, announced the completion of a European Phase 2 study (MP18), an open-label, multicenter…
- NORTHBROOK, Ill., April 23, 2024 – Endevica Bio, a company developing first-in-class peptide drug candidates, announced its novel weight-loss treatment was successful in a recent diet-induced obesity (DIO) rat study. This latest research solidifies…
- SHANGHAI, April 19, 2024. GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925…
Daily Med News
- FRIDAY, April 26, 2024 — The U.S. Department of Agriculture is clamping down on salmonella bacteria found in breaded, stuffed raw chicken products, with the agency issuing a final rule on the issue Friday. The agency's Food Safety and Inspection…
- FRIDAY, April 26, 2024 — Each year, thousands of Americans head home after a surgery clutching prescription opioids to help ease post-surgical pain. Trouble is, most won't use all those pills, and that could lead to a lot of misuse and addiction,…
- FRIDAY, April 26, 2024 (HealthDay) — Between 2018 and the spring of 2023, a cluster of clients who had gotten 'vampire facial' microneedling skin treatments at a New Mexico spa were diagnosed with HIV, probably via poorly cleaned instruments, a new…
- FRIDAY, April 26, 2024 — Bits of bird flu virus have been discovered in roughly 20% of retail milk samples tested in a national survey, the U.S. Food and Drug Administration said Thursday. The finding suggests that bird flu has spread far more…
- FRIDAY, April 26, 2024 — Want to live longer? Choose the stairs over the elevator, a new review suggests. Folks who regularly climb stairs have a 24% reduced risk of dying from any cause, and a 39% reduced risk of dying from heart disease,…
News for Health Professionals
- FRIDAY, April 26, 2024 — Nearly two-thirds of survivors of severe COVID-19 discharged to long-term acute care hospitals have persistent impairments at one year, according to a study published online April 10 in Critical Care Medicine.Anil…
- FRIDAY, April 26, 2024 — In 2023, birth rates in the United States were down, according to an April Vital Statistics Rapid Release provisional report, a publication from the National Center for Health Statistics.Brady E. Hamilton, Ph.D., from the…
- FRIDAY, April 26, 2024 — Serum biomarkers can predict knee osteoarthritis before radiographic abnormalities, according to a study published in the April 26 issue of Science Advances. Virginia Byers Kraus, M.D., Ph.D., from the Duke Molecular…
- FRIDAY, April 26, 2024 — Administration of antenatal corticosteroids to persons at risk for late preterm delivery is not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older, according to a study published online…
- FRIDAY, April 26, 2024 — Use of acid-suppression therapy is associated with higher odds of migraine or severe headache, according to a study published online April 24 in Neurology: Clinical Practice. Margaret Slavin, Ph.D., from the University of…
