Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Consumer December 16, 2024 – Los Angeles, California – Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See below for photo of product labeling. Fouzee Sugarlin Herbal…
- Audience: Patient, Health Professional, OBGYN, Endocrinology Update: December 16, 2024FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated with use of menopause medicine Veozah…
- Audience: Gastroenterology, Hepatology, Patient, Health Care Professional, Pharmacy ISSUE: The FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did…
- Audience: Consumer Flushing, New York, Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide…
- FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)Audience: Health Professional November 27, 2024 — Since approval, the Food and Drug Administration (FDA) has received additional reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome and acute myeloid…
New Drug Approvals
- INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe…
- PLAINSBORO, N.J., Dec. 20, 2024 /PRNewswire/ — Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding…
- CARLSBAD, Calif., Dec. 19, 2024 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults…
- NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil (remestemcel-L)…
- On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who…
New Drug Applications
- Copenhagen, Denmark, December 19, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that…
- CHATHAM, N.J., Dec. 17, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA)…
- SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a…
- NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has…
- DURHAM, N.C., Nov. 26, 2024 /PRNewswire/ — Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), are pleased to announce that the U.S. Food and Drug…
Clinical Trial Results
- SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and…
- TARRYTOWN, N.Y., December 19, 2024 – Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer…
- December 17, 2024 — New NIH-funded data show lower use of most substances continues following the COVID-19 pandemic. If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat at 988lifeline.org. To learn…
- SALT LAKE CITY, Dec. 17, 2024 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and…
- RAHWAY, N.J.–(BUSINESS WIRE) December 16, 2024 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and…
Daily Med News
- SATURDAY, Dec. 21, 2024 — The holiday spirit is infectious, even for people suffering from dementia. But family and friends might need to make some slight adjustments to help a dementia patient better enjoy the holidays, the Alzheimer’s…
- FRIDAY, Dec. 20, 2024 — An outbreak of salmonella linked to cucumbers has now been tied to 100 known cases of the illness across 23 states, the U.S. Food and Drug Administration reported Thursday. That's up from 68 cases reported in the FDA's last…
- FRIDAY, Dec. 20, 2024 — Holy chip! Frito-Lay has issued a limited recall of select 13-oz bags of Lay’s Classic Potato Chips due to the potential presence of undeclared milk, which could pose a serious health risk to individuals with a milk…
- FRIDAY, Dec. 20, 2024 — Just over 300 people have been sickened in norovirus outbreaks on three different cruise ships in December, new government data shows. This is the only month this year in which the U.S. Centers for Disease Control and…
- FRIDAY, Dec. 20, 2024 — Sexism is incredibly toxic to women’s lives, resulting in lower pay, fewer career opportunities, worse health care and a greater risk of violence. It also can be toxic to their brain health, a new study says. U.S…
News for Health Professionals
- FRIDAY, Dec. 20, 2024 — Frito-Lay has recalled select 13-oz bags of Lay's Classic Potato Chips due to undeclared milk, which could pose a serious risk to those with milk allergies. According to a report released by the U.S. Food and Drug…
- FRIDAY, Dec. 20, 2024 — Early adoption and implementation of Tobacco 21 (T21) policies, with a minimum legal access age for tobacco products of 21 years, is associated with potential premature mortality reductions, according to a study published…
- FRIDAY, Dec. 20, 2024 — For individuals with type 2 diabetes, examination with vibration-controlled transient elastography (VCTE) alongside retina scanning has a high acceptance rate, but false-positive findings seem to be common, according to a…
- FRIDAY, Dec. 20, 2024 — Sexual minority women (SMW) report better sexual functioning in midlife than their heterosexual peers, according to a study published online Dec. 17 in Menopause. Laura A. Muratore, from the San Francisco Veterans Affairs…
- FRIDAY, Dec. 20, 2024 — For patients with advanced breast cancer and baseline clinical anxiety, cannabidiol (CBD) is safe and may reduce anxiety levels two to four hours after ingestion, according to a study published online Dec. 16 in JAMA Network…
