Pharmaceutical
FDA MedWatch Drug Alerts
- 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…
- Audience: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc…
- Audience: Healthcare Provider, Pharmacy, Consumer NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of Prograf® 0.5mg (tacrolimus) and one lot…
- Audience: Healthcare Provider, Pharmacy, Consumer December 21, 2024 – Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the…
- Audience: Healthcare Professional, Pharmacy, Consumer MALVERN, PA, December 20, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots…
New Drug Approvals
- Titusville, New Jersey, January 21, 2025 – Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray, making…
- WILMINGTON, Del.– January 17, 2025 — Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC…
- 17 January 2025 — AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible…
- THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of adult…
- INDIANAPOLIS, Jan. 15, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease…
New Drug Applications
- PASADENA, Calif.–(BUSINESS WIRE)–Jan. 17, 2025– Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational…
- THOUSAND OAKS, Calif.–(BUSINESS WIRE) January 16, 2025 — Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for…
- SHANGHAI, Jan. 7, 2025 /PRNewswire/ — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has…
- SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of the…
- BOSTON–(BUSINESS WIRE)–Dec. 30, 2024– Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted for…
Clinical Trial Results
- WALTHAM, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing life-transforming therapeutics for people living with genetically driven diseases, today…
- Ingelheim, Germany, January 16, 2025 – Boehringer Ingelheim today announced top-line results from the Phase III CONNEX clinical program in cognitive impairment in adults with schizophrenia, showing primary and key secondary endpoints were not…
- Philadelphia, Pennsylvania and Oxford, United Kingdom–(Newsfile Corp. – January 13, 2025) – Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, today announced that…
- 13 January 2025 — AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or…
- CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas…
Daily Med News
- WEDNESDAY, Jan. 22, 2025 — Efforts to limit access to the abortion drug mifepristone have received a boost from a federal judge who took the bench during President Donald Trump's first term. U.S. District Judge Matthew Kacsmaryk ruled that…
- WEDNESDAY, Jan. 22, 2025 — The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants…
- WEDNESDAY, Jan. 22, 2025 — Abortion information is disappearing from federal government websites, signaling potential changes in abortion under the second Trump administration. ReproductiveRights.gov, a site launched under the Biden…
- WEDNESDAY, Jan. 22, 2025 — Could eating more fiber be the key to a healthier gut? Research suggests the answer is yes. The findings, published recently in the journal Nature Microbiology, analyzed gut microbiomes from more than 12,000 people in 45…
- WEDNESDAY, Jan. 22, 2025 — With a sweep of the pen, President Donald Trump has ended a Biden administration effort to lower the cost of prescription drugs for people on Medicare and Medicaid. Trump's order, signed shortly after his inauguration on…
News for Health Professionals
- WEDNESDAY, Jan. 22, 2025 — In one of his first presidential actions on Monday, President Trump issued an executive order withdrawing the United States from the World Health Organization. The executive order retracts a Presidential Letter by…
- WEDNESDAY, Jan. 22, 2025 — Fourteen-day continuous glucose monitoring (CGM) traces added to Diabetes Control and Complications Trial (DCCT) data can predict microvascular diabetes complications similarly to glycated hemoglobin, according to a study…
- WEDNESDAY, Jan. 22, 2025 — Machine learning models may be able to identify women with severe subjective cognitive decline (SCD) during the menopause transition, according to a study published online Jan. 14 in Menopause. Xiangyu Zhao, from…
- WEDNESDAY, Jan. 22, 2025 — Pregnancies resulting from assisted reproductive technology (ART) have a higher prevalence of exposure to teratogenic medicines, according to a study published online Dec. 9 in the Australian and New Zealand Journal of…
- WEDNESDAY, Jan. 22, 2025 — Self-reported manifestations of topical steroid withdrawal (TSW) in atopic dermatitis (AD) include erythema, desquamation, dryness, and oozing affecting the face, neck, and upper extremities, according to a study…
