FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
On Dec. 1, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of agentic AI capabilities…
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FDA Withdraws Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
On Nov. 28, 2025, The Food and Drug Administration (FDA) announced the withdrawal of the proposed rule entitled…
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U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer
On Nov. 21, 2025, Pfizer and Astellas Pharma announced that the U.S. Food and Drug Administration (FDA) has…
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Biotechnology | FDA | Oncology | Therapeutics
FDA approves first cancer drug based on Broad Institute science
On Nov. 20, 2025, the US Food and Drug Administration (FDA) has approved the first cancer drug based…
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Biotechnology | Cardiology | Clinical Research | CRISPR | Disease | FDA | Genomics | HIV | Infectious Disease | Influenza | Nanotechnology | Neurology | NIH | Oncology | Organ Transplant | Rare Disease | Stem Cell | Therapeutics | U.S. Congress | Vaccine | Women's Health
Halted NIH Clinical Trials List Reveals Slashed Treatments for Cancer, COVID and Minority Health
On Nov. 20, 2025, the National Institutes of Health (NIH) has canceled funding for at least 383 clinical…
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Arrowhead Pharma Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)
On Nov. 18, 2025, Arrowhead Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO…
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Biotechnology | Disease | FDA | Therapeutics
Sandoz launches TYRUKO® (natalizumab-sztn) in US, as first and only multiple sclerosis biosimilar
On Nov. 17, 2025, Sandoz announced that TYRUKO® (natalizumab-sztn) is available to patients in the US. Developed by…
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FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others
On Nov. 13, 2025, the U.S. Food and Drug Administration (FDA) approved multiple denosumab biosimilars, enhancing market access…
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FDA reverses decades-old warning on hormone therapy products for menopause
On Nov. 10, 2025, the Food and Drug Administration (FDA) is reversing a 2003 decision that put a…
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Biotechnology | FDA | Medicine | Therapeutics
Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans
On Nov. 6, 2025, Eli Lilly announced an agreement with the U.S. government to expand access to its…
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Biotechnology | Disease | FDA | Therapeutics
FDA approves menin inhibitor for patients with acute leukemia with NPM1 mutation, backed by Dana-Farber science
On Nov. 4, 2025, the U.S. Food and Drug Administration (FDA) approved revumenib, a first-in-class oral menin inhibitor,…
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FDA to Accelerate Biosimilar Development and Lower costs
On Oct. 29, 2025, the U.S. Food and Drug Administration (FDA) announced it is aiming to reduce the…
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Lilly partners with Nvidia on AI supercomputer to speed up drug development
On Oct. 28, 2025, Eli Lilly said on Tuesday it was collaborating with Nvidia to build a supercomputer…
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Qureator Achieves World’s First FDA IND Approval Using Only Human Vascularized Organoid Efficacy Data
On Oct. 27, 2025, Qureator announced a major milestone, confirming a fundamental shift in drug development under the…
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Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma
On Oct. 23, 2025, GSK announced the US Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf)…
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Glaukos Announces FDA Approval of Epioxa™
On Oct. 20, 2025, Glaukos announced today the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD…
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FDA approves Novo Nordisk’s oral semaglutide for cardiovascular risk reduction in adults with type 2 diabetes
On Oct. 17, 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-1…
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Diagnostics | Disease | FDA | Medicine | Pharmaceutical | Therapeutics
FDA unveils drugs to receive expedited review in support of ‘national priorities’
On Oct. 16, 2025, the Food and Drug Administration (FDA) announced the first round of experimental drugs that…
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Biotechnology | Diagnostics | Disease | FDA | Neurology | NIH
Alzheimer’s Association Welcomes FDA Clearance of First Blood Test for Use in Primary Care to Rule Out Alzheimer’s-Related Amyloid Pathology
On Oct. 13, 2025, the U.S. Food and Drug Administration (FDA) announces it has cleared the Elecsys pTau181…
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U.S. FDA approves Boehringer’s JASCAYD® (nerandomilast) tablets as first new treatment option for adults with IPF in over a decade
On Oct. 9, 2025, Boehringer Ingelheim’s JASCAYD® (nerandomilast) tablets has been approved by the U.S. Food and Drug…
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Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)
On Oct. 9, 2025, Celltrion announced announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar…
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FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing
On Oct. 3, 2025, the U.S. Food and Drug Administration (FDA) announced a new pilot prioritization program for…
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FDA approved Evita Solution’s generic version of the abortion drug, mifepristone
On Oct. 2, 2025, the U.S. Food and Drug Administration (FDA) approved Evita Solution’s generic version of the…
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FDA Takes Action to Make a Treatment Available for Autism Symptoms
On Sept. 22, 2025, the U.S. Food and Drug Administration (FDA) announced it h initiated the approval of…
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Biotechnology | Disease | FDA | Therapeutics
Corstasis Therapeutics Announces FDA Approval of ENBUMYST™ (bumetanide nasal spray) for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease
On Sept. 15, 2025, Corstasis Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved ENBUMYST™…
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Agriculture | Diagnostics | FDA | Infectious Disease | Influenza | USDA
USDA Confirms Highly Pathogenic Avian Influenza in Dairy Herd in Nebraska
On Sept. 15, 2025, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) National…
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Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula
On Sept. 8, 2025, Pfizer and BioNTech announced positive topline results from an ongoing Phase 3 clinical trial…
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Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | NIH | Vaccine | Women's Health
Hawaii to join West Coast Health Alliance with California, Oregon, and Washington
On Sept. 4, 2025, roughly 24 hours after the launch of the West Coast Health Alliance, Hawaii is…
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Nuvaxovid® Now Approved in Japan Triggering Takeda Milestone Payment
On Sept. 4, 2025, Novavax announced a milestone payment from Takeda has been triggered by regulatory approval for Novavax’s…
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Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | NIH | Vaccine | Women's Health
California, Oregon, and Washington to launch new West Coast Health Alliance to uphold scientific integrity in public health as Trump destroys CDC’s credibility
On Sept. 3, 2025, California Governor Gavin Newsom, Oregon Governor Tina Kotek, and Washington Governor Bob Ferguson announced…
