Pharmaceutical
FDA News & Events
FDA MedWatch Drug Alerts
- Audience: Consumer, Health Professional, Pharmacy March 12, 2024 – DUBLIN, Ireland – Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of…
- Audience: Consumer, Health Professional, Pharmacy, Ophthalmology 22 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging…
- Audience: Consumers Watsonville, Calif. (Feb. 17, 2024) – Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid, 0.76 fl. oz. (22.5 mL), 400 IU (10mcg) D3. This recall is being conducted due to a…
- Audience: Consumers, Health Care Providers, Health Care Facilities Update: February 6, 2024 Additional Related Recalls of Saline and Sterile Water Medical Products Associated with Nurse Assist In direct response to the Nurse Assist, LLC recall on…
- Audience: Consumers February 2, 2024 – VANCOUVER, WA, "Today The World" is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to…
New Drug Approvals
- TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) — Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the U.S. Food and…
- YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) — Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has…
- CONSHOHOCKEN, Pa., March 14, 2024 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food and…
- BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)– BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved…
- PRINCETON, N.J.–(BUSINESS WIRE) Mar 14, 2024 — Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed…
New Drug Applications
- NEWTON, Massachusetts March 6, 2024 – Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer, today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and…
- CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has extended the review period…
- BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the…
- Malvern, PA, and Parsippany, NJ – February 23, 2024 – Venatorx Pharmaceuticals (Venatorx) and Melinta Therapeutics (Melinta) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL)…
- TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for…
Clinical Trial Results
- JERSEY CITY, N.J., March 18, 2024. Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of results in The Lancet Neurology from the pivotal, Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy, safety and…
- March 18, 2024 — Fenoprofen, a nonsteroidal anti-inflammatory drug (NSAID), successfully alleviated pain and inflammation in a rodent model of endometriosis, according to researchers funded by the National Institutes of Health (NIH). They chose the…
- NEW YORK, March 14, 2024. myTomorrows today announced a new partnership with the ALS Association, the U.S.-based nonprofit organization fighting ALS on every front. myTomorrows is a global health technology company shaping the future landscape of…
- FOSTER CITY, Calif.–(BUSINESS WIRE) March 14, 2024 — Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies,…
- LEXINGTON, Mass., March 14, 2024 (GLOBE NEWSWIRE) — Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of…
Daily Med News
- MONDAY, March 18, 2024 — The last remnants of asbestos use in the United States have now been banned by the Environmental Protection Agency. While the known carcinogen has already been largely banned, the EPA announced Monday that it would ban the…
- MONDAY, March 18, 2024 — Middle-aged Americans are lonelier than ever, with new research showing they are even more isolated than some of their peers in Europe. That does not bode well for their health. "Loneliness is gaining attention globally…
- MONDAY, March 18, 2024 — As millions of Americans prepare to travel abroad this summer and measles outbreaks increase worldwide, the U.S. Centers for Disease Control and Prevention has tightened its guidance on how travelers should handle the…
- MONDAY, March 18, 2024 — High school students who use tobacco and cannabis products miss more school and have lower grades than classmates who use them individually or not at all. That's the conclusion of a study by researchers at UC Davis…
- MONDAY, March 18, 2024 — Over the first few years of a child's life, foods found in a family's fridge and cupboards tends to get less healthy, new research shows. “We found significant changes in several food categories over time," said…
News for Health Professionals
- MONDAY, March 18, 2024 — The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory…
- MONDAY, March 18, 2024 — Childhood lead exposure is widespread in Chicago and there are racial inequities evident in testing rates and exposure levels, according to a study published online March 18 in JAMA Pediatrics.Benjamin Q. Huynh, Ph.D.,…
- MONDAY, March 18, 2024 — There is little to no difference in the effectiveness of in-person versus therapist-guided remote cognitive behavioral therapy (CBT) across a range of mental health and somatic disorders, according to a review published in…
- MONDAY, March 18, 2024 — Some U.S. government personnel have reported dizziness, pain, visual problems, and cognitive dysfunction after experiencing intrusive sounds and head pressure, termed anomalous health incidents (AHIs), but no differences…
- MONDAY, March 18, 2024 — Polygenic risk scores (PRSs) derived from the general population are associated with a subsequent risk for certain cancers among survivors of childhood cancer, with an additive risk for PRS and radiotherapy, according to a…