FDA approves Novo Nordisk’s Wegovy® pill, the first and only oral GLP-1 for weight loss in adults
On Dec. 22, 2025, Novo Nordisk announced announced that the US Food and Drug Administration (FDA) has approved…
FDA Announces Approval of Cytokinetics’ MYQORZO™ (aficamten) for Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
On Dec. 19, 2025, Cytokinetics announced that the U.S. Food and Drug Administration (FDA) has approved MYQORZO™ (aficamten),…
Space Station Research Supports New FDA-Approved Cancer Therapy
On Dec. 18, 2025, the National Aeronautics and Space Administration (NASA) announced it has opened the International Space…
Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP‑1 and amylin analogues for weight management
On Dec. 18, 2025, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S….
Biotechnology | Disease | FDA | Therapeutics
FDA Approves Two Oral Therapies to Treat Gonorrhea
On Dec. 12, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved two new oral…
FDA Approves USAntibiotics’ Augmentin XR in Historic First for Expedited Review Program
On Dec. 11, 2025, USAntibiotics, the country’s only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced…
FDA | Medicine | Therapeutics
Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals
On Dec. 9, 2025, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the…
Biotechnology | CRISPR | Disease | FDA | Genomics | Stem Cell | Therapeutics
FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
On Dec. 8, 2025, the U.S. Food and Drug Administration (FDA) approved two milestone treatments, Casgevy and Lyfgenia,…
Biotechnology | CDC | Diagnostics | Disease | FDA | Vaccine | Women's Health
US vaccine advisers say not all babies need a hepatitis B shot at birth
On Dec. 5, 2025, a federal vaccine advisory committee voted on Friday to end the longstanding recommendation that…
Biotechnology | CDC | Disease | FDA | Vaccine
The West Coast Health Alliance, CDPH, and Leading National Medical Organizations Continue to Recommend Hepatitis B Vaccination for Newborns
On Dec. 5, 2025, the West Coast Health Alliance (WCHA) announced that it strongly supports that hepatitis B…
Merck Product first in its class and the only product conditionally approved by FDA for both prevention and treatment of New World screwworm
On Dec. 4, 2025, Merck Animal Health announced the U.S. Food and Drug Administration (FDA) has granted a…
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…
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…
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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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…
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…
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…
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…
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…
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,…
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…
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…