Pharmaceutical
FDA MedWatch Drug Alerts
- Audience: Consumer, Health Professional, Pharmacy February 13, 2025 LAKE FOREST, Illinois – ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM…
- Audience: Consumer, Health Professional, Pharmacy January 31, 2025 – Morristown, NJ — Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall…
- Audience: Pharmacy, Consumer January 24, 2025 – Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk…
- Audience: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients…
- Audience: Health Care Professionals January 16, 2025 — FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Health care professionals…
New Drug Approvals
- February 14, 2025 — Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus…
- INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Xbryk (denosumab-dssb; SB16; 120 mg vial), a biosimilar…
- INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe)…
- London, UK – 15 February 2025 – GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The…
- COPENHAGEN, Denmark, February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has approved Vimkunya (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle…
New Drug Applications
- WARREN, N.J., Feb. 19, 2025 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of children…
- DURHAM, N.C., Feb. 18, 2025 (GLOBE NEWSWIRE) — Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the U.S…
- NEW HAVEN, Conn., Feb. 11, 2025 /PRNewswire/ — Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for troriluzole for…
- TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA)…
- CINCINNATI- February 10, 2025 –LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) of…
Clinical Trial Results
- Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes…
- Ridgefield, Conn., and Ingelheim, Germany, Feb. 19, 2025 — Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment…
- February 17, 2025 — Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to…
- PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ — PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track…
- Wed, Feb 12, 2025 — The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). Lundbeck has recently initiated MASCOT, a phase III trial…
Daily Med News
- FRIDAY, Feb. 21, 2025 — New York Attorney General Letitia James filed a major lawsuit yesterday, accusing 13 e-cigarette companies of illegally selling flavored vapes and targeting young kids through deceptive marketing.The 192-page complaint…
- FRIDAY, Feb. 21, 2025 — Adding a personalized mRNA vaccine to standard treatment could offer new hope for pancreatic cancer patients, a small yet promising study from Memorial Sloan Kettering Cancer Center.The study followed 16 patients, including…
- FRIDAY, Feb. 21, 2025 — Got milk? It turns out, plain cow’s milk, water and a bit of veggie juice are still the best drink choices for kids and teens.That's the consensus of experts who recently issued healthy beverage recommendations for kids and…
- FRIDAY, Feb. 21, 2025 — One of the NBA's most exciting rising stars will spend the rest of the 2024-2025 season on the bench. Victor Wembanyama, the San Antonio Spurs' 7-foot 3-inch phenom, was sidelined after doctors discovered a dangerous blood…
- FRIDAY, Feb. 21, 2025 — America’s opioid crisis is showing signs of subsiding, a new report from the U.S. Centers for Disease Control and Prevention (CDC) says. Drug overdose deaths (OD) decreased by 4% between 2022 and 2023, according to…
News for Health Professionals
- FRIDAY, Feb. 21, 2025 — Postpandemic hospital occupancy is higher than prepandemic and is expected to continue increasing without changes in the hospitalization rate or staffed hospital bed supply, according to a research letter published online…
- FRIDAY, Feb. 21, 2025 — Cancer mortality has decreased among Black Americans, but they still have elevated mortality rates compared with White Americans, according to a study published online Feb. 20 in CA: A Cancer Journal for Clinicians.Anatu H…
- FRIDAY, Feb. 21, 2025 — About 69 percent of U.S. counties do not have a gastroenterologist, according to a research letter published online Feb. 6 in Gastroenterology.Xiaohan Ying, M.D., from Weill Cornell Medicine in New York City, and colleagues…
- FRIDAY, Feb. 21, 2025 — Higher calcium intake is associated with reduced colorectal cancer (CRC) risk across tumor sites and calcium sources, according to a study published online Feb. 17 in JAMA Network Open.Semi Zouiouich, Ph.D., M.P.H., from…
- FRIDAY, Feb. 21, 2025 — There is some evidence for epidural steroid injections (ESIs) reducing pain and disability in cervical and lumbar radiculopathies and possibly in lumbar spinal stenosis, according to a study published online Feb. 12 in…
