Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Health Care Professionals April 29, 2024 — FDA is alerting health care professionals of the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines (azathioprine, 6-mercaptopurine, and…
- 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…
New Drug Approvals
- WOBURN, Mass. May 6, 2024 – Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug…
- RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's…
- SAN DIEGO, April 30, 2024 /PRNewswire/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral granules formulation of Ingrezza…
- WARREN, N.J., April 29, 2024 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives…
- BOSTON, April 29, 2024 (GLOBE NEWSWIRE) — X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has approved…
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
- STOCKHOLM, May 6, 2024. Calliditas Therapeutics AB ("Calliditas") today announced data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell…
- SAN ANTONIO, May 3, 2024. Johnson & Johnson announced today results from the open-label, single-arm Phase 2 Apa-RP study evaluating adjuvant treatment with ERLEADA (apalutamide) and androgen deprivation therapy (ADT) in patients with HRLPC who…
- Lyon, France, and Cambridge, MA, May 2, 2024 — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that eneboparatide, its lead therapeutic peptide candidate…
- NEW YORK, May 1, 2024. Gilgamesh Pharmaceuticals, a clinical-stage neuroscience company committed to developing best-in-class, rapid-acting treatments for central nervous system disorders, today announced the initiation of patient dosing with…
- May 1, 2024 — Researchers have discovered that choline, an essential nutrient vital for brain health, is actively transported from the bloodstream into the brain by a protein. The findings may inform the development of new drugs that take advantage…
Daily Med News
- WEDNESDAY, May 8, 2024 — Dogs brought into the United States from abroad must be compliant with new rules to help fight rabies in this country, according to updated guidance from the Centers for Disease Control and Prevention issued…
- WEDNESDAY, May 8, 2024 — More than 320,000 U.S. children lost a parent to drug overdose during the past decade, according to a new study reported May 8 in JAMA Psychiatry. What’s more, the death rate accelerated during the period, more than…
- WEDNESDAY, May 8, 2024 — Nine of 10 American adults are in the early, middle or late stages of a syndrome that leads to heart disease, a new report finds, and almost 10% have the disease already. "Poor cardiovascular, kidney, and metabolic health…
- WEDNESDAY, May 8, 2024 — The virus behind COVID has mutated again, this time producing variants nicknamed FLiRT, the U.S. Centers for Disease Control and Prevention (CDC) has reported. The variants are appearing in wastewater sampling, the CDC…
- THURSDAY, May 8, 2024 — Parents striving to be “perfect” will never attain that goal, and the aim isn’t even healthy for their families, a new study says. The risks of striving for perfection are such that researchers have now…
News for Health Professionals
- WEDNESDAY, May 8, 2024 — From 2011 to 2021, an estimated 321,566 children lost a parent to drug overdose in the United States, according to a study published online May 8 in JAMA Psychiatry.Christopher M. Jones, Pharm.D., Dr.P.H., M.P.H., from the…
- WEDNESDAY, May 8, 2024 — Three-quarters of U.S. adults believe mental health issues are identified and treated worse than physical health issues, according to the results of a survey released by West Health and Gallup.The web survey was conducted…
- WEDNESDAY, May 8, 2024 — Distal symmetric polyneuropathy (DSP) is common and is frequently undiagnosed, according to a study published online May 8 in Neurology.Melissa A. Elafros, M.D., Ph.D., from the University of Michigan in Ann Arbor, and…
- WEDNESDAY, May 8, 2024 — Procedure risk is more strongly associated with outcomes in older patients undergoing emergency general surgery than assessing frailty, according to a study published online April 25 in the Journal of the American…
- WEDNESDAY, May 8, 2024 — There is consistent evidence that high cardiorespiratory fitness (CRF) is strongly associated with a lower risk for a variety of cardiovascular disease outcomes, according to a review published online May 2 in…
