Dr. Delese Mimi Darko Appointed Inaugural Director General of the African Medicines Agency (AMA)
On Jun. 4, 2025, the Conference of State Parties (CoSP) of the African Medicines Agency (AMA) announced the…
Artificial Intelligence | Biotechnology | Diagnostics | FDA | Medical Device | Pharmaceutical | Therapeutics | Vaccine | Women's Health
FDA Launches Agency-Wide AI Tool to Optimize Performance
On Jun. 2, 2025, the U.S. Food and Drug Administration (FDA) announces it has launched Elsa, a generative…
Moderna Received U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE
On May 31, 2025, Moderna announced that the U.S. Food and Drug Administration (FDA) had approved mNEXSPIKE® (mRNA-1283),…
New vaccine policy limits access to COVID shots
On May 20, 2025, The Trump administration said it will limit approval for seasonal COVID-19 shots to seniors…
FDA approves Novavax COVID vaccine with new conditions
On May 17, 2025, The U.S. Food and Drug Administration approved Novavax’s COVID-19 vaccine, but placed additional conditions…
Biology | Diagnostics | Disease | FDA | Medical Device | Neurology | Therapeutics
FDA clears first blood test for Alzheimer’s detection
On May 16, 2025, the U.S. Food and Drug Administration has cleared Fujirebio Diagnostics’ blood test to diagnose…
Disease | FDA | Neurology | Pharmaceutical | Therapeutics
Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for Acute Treatment of Migraine
On May 15, 2025, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya®…
Biotechnology | Disease | FDA | Oncology
US FDA approves AbbVie’s drug for a type of lung cancer
On May 14, 2025, The U.S. Food and Drug Administration (FDA) has approved AbbVie’s drug to treat adults…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Women's Health
FDA Approves Teal Health’s Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening
On May 9, 2025, Teal Health® announced the Food and Drug Administration’s (FDA) approval of the Teal Wand™,…
Biology | Chemistry | Environmental | EPA | FDA | Marine Science | Medicine | Pharmaceutical
Antibiotics from human use are contaminating rivers worldwide, study shows
On May 9, 2025, a McGill University led team of researchers announced a study that shows an estimated…
Agriculture | Biotechnology | Diagnostics | Disease | FDA | Veterinary
FDA approves gene-editing tech creating PRRS-resistant pigs
On Apr. 30, 2025, the U.S. Food and Drug Administration (FDA) approved the use of a gene-editing technology…
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Cartoon Illustrating “The NIH and U.S. Healthcare in Crisis” Published
On Apr. 21, 2025, LifeScienceHistory.com published the cartoon: “The National Institutes of Health (NIH) and U.S. Healthcare in…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics | USDA
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
On Apr. 10, 2025, the U.S. Food and Drug Administration announced it is taking a groundbreaking step to…
Revvity Secures FDA Approval for Improved Automated Latent Tuberculosis Test
On Apr. 2, 2025, Revvity announced that the U.S. Food and Drug Administration (FDA) has approved the Auto-Pure…
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HHS starts layoffs of thousands of workers across its agencies
On Apr. 1, 2025, layoff notices began arriving for thousands of employees of the sprawling U.S. Department of…
Biotechnology | Disease | FDA | Rare Disease
FDA Approved Qfitlia™ (fitusiran), the First siRNA (RNAi Therapeutic) for the Treatment of Hemophilia A or B
On Mar. 28, 2025, the U.S. Food and Drug Administration (FDA) announced approval of Alnylam Pharmaceuticals Qfitlia™ (fitusiran),…
Disease | FDA | Rare Disease
Alnylam Announces FDA Approval of AMVUTTRA® (vutrisiran), the First RNAi Therapeutic to Reduce Cardiovascular Death, Hospitalizations and Urgent Heart Failure Visits in Adults with ATTR Amyloidosis
On Mar. 20, 2025, Alnylam Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approval of the supplemental…
FDA Releases Influenza Vaccine Composition for the 2025-2026 U.S. Influenza Season
On Mar. 13, 2025, the U.S. Food and Drug Administration (FDA) announced recommendations to vaccine manufacturers for the…
U.S. FDA approves Celltrion’s OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
On Mar. 9, 2025, Celltrion announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and…
Diagnostics | Disease | FDA | Medical Device | Non-Profit Research | Ophthalmogy | Rare Disease | Therapeutics
FDA approves ENCELTO, a first-of-its-kind eye implant that slows vision loss in rare eye disease
On Mar. 6, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of ENCELTO (revakinagenetaroretcel-lwey), a…
Biotechnology | Disease | FDA | Medicine | Neurology | Therapeutics
FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
On Mar. 3, 2025, Genentech announced that the U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase),…
Biotechnology | Diagnostics | Disease | FDA | Therapeutics
FDA approves ODACTRA® for the treatment of house dust mite allergy in young children
On Feb. 27, 2025, ALK announced that the U.S. Food and Drug Administration (FDA) has approved ALK’s ODACTRA®…
Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay
On Feb. 18, 2025, Hologic announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance…
Biotechnology | Disease | FDA | Neurology | Therapeutics
FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy
On Feb. 12, 2025, Genentech announced that the U.S. Food and Drug Administration (FDA) has approved a New…
Biotechnology | Disease | FDA | Neurology | Ophthalmogy | Therapeutics
FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
On Feb. 4, 2025, Genentech announced that the U.S. Food and Drug Administration (FDA) had approved Susvimo® (ranibizumab…
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
On Jan. 30, 2025, the U.S. Food and Drug Administration (FDA) approved Vertex Pharmaceuticals’s Journavx (suzetrigine) 50 milligram…
Biotechnology | Disease | FDA | Therapeutics
FDA approves Ozempic® (semaglutide) as only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and CKD
On Jan. 28, 2025, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® to…
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U.S. FDA drops Support improving clinical trial diversity
Jan. 24, 2025, the U.S. Food and Drug Administration (FDA) pulled draft guidance from its website requiring companies…
Chemistry | FDA | Materials | Oncology | Pharmaceutical | U.S. Congress
U.S. FDA Revokes Authorization for the Use of Red No. 3 in Food and Ingested Drugs
On Jan. 15, 2025, the U.S. Food and Drug Administration (FDA) announced revoking the authorization for the use…
Biotechnology | Diagnostics | FDA | Medical Device | Medicine | Pharmaceutical | Rare Disease | Therapeutics
U.S. Food and Drug Administration approved 50 new therapeutics in 2024
On Jan. 14, 2025, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced…