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…
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…
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)…
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…
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…
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…
Biotechnology | Diagnostics | Disease | FDA | 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…
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…
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…
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…
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…
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…
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™…
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…
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…
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…
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…
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…
Novavax’s Nuvaxovid™ 2025-2026 Formula COVID-19 Vaccine Approved in the U.S.
On Aug. 27, 2025, Novavax announced that the U.S. Food and Drug Administration (FDA) has approved the Nuvaxovid™ 2025-2026…
Valneva shares tumble after suspension of U.S. chikungunya vaccine license
On Aug. 25, 2025, shares of French drugmaker Valneva slumped more than 20% after the U.S. Food and…
In a Major Win for Vanda, a Federal Appeals Court Overturns FDA’s Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
On Aug. 18, 2025, Vanda Pharmaceuticals announced that it secured a landmark victory over the U.S. Food and…
Biotechnology | Disease | FDA | Medicine | Therapeutics
Novo Nordisk lowers cost of Ozempic® to $499 per month for self-paying patients
On Aug. 18, 2025, Novo Nordisk announced the launch of a new offer that enables self-paying, eligible, type…
Biotechnology | Disease | FDA | Therapeutics
Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis
On Aug. 15, 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a…
Precigen Announces FDA Approval of PAPZIMEOS, the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
On Aug. 15, 2025, Precigen announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba)…
Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
U.S. abandons mRNA vaccine development despite triumphs
On Aug. 8, 2025, the U.S.Department of Health and Human Services (HHS) announced that it was winding down…
Washington Health Officials investigating possible locally acquired case of malaria
On Aug. 6, 2025, the Tacoma-Pierce County Health Department (TPCHD) reported an East Pierce County, Washington woman who…
Biotechnology | Disease | FDA | Therapeutics
FDA approves Alhemo® as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B
On Jul. 31, 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) approved Alhemo® (concizumab-mtci)…
Biogen Announces $2 Billion Manufacturing Investment in North Carolina’s Research Triangle Park
On Jul. 21, 2025, Biogen announced it intends to invest an additional $2 billion in its existing manufacturing…
Biotechnology | Disease | FDA | Therapeutics
FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys; Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
On Jul. 18, 2025, the U.S. Food and Drug Administration (FDA) announced it has placed Sarepta Therapeutics investigational…
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
On Jul. 10, 2025, Moderna announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental…