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…
Biotechnology | Diagnostics | Disease | FDA | Medicine | Neurology | NIH | Oncology | Therapeutics | U.S. Congress | Vaccine | Women's Health
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Jan. 24, 2025, the U.S. Food and Drug Administration (FDA) pulled draft guidance from its website requiring companies…
Chemical | 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…
Biotechnology | Diagnostics | Disease | FDA | Neurology
FDA Issues Final Guidance for Industry on Action Levels for Lead in Processed Food for Babies and Young Children
On Jan. 6, 2025, the U.S. Food and Drug Administration (FDA) issued guidance for industry on the action…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics
U.S. FDA Approved Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
On Dec. 20, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved BRAFTOVI® (encorafenib)…
Biotechnology | Diagnostics | Disease | FDA | Therapeutics
FDA approved Alhemo® injection as once-daily prophylactic treatment to reduce frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B
On Dec. 20, 2024, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had approved Alhemo®…
Agriculture | Biotechnology | Chemical | Environmental | FDA
FDA updates Definition of “Healthy Foods” For Packaging, first time in three decades
On Dec. 19, 2024, the U.S. Food and Drug Administration announced it had updated the definition of “healthy…
Artificial Intelligence | Biotechnology | FDA | Genomics | Infectious Disease | Stem Cell | Therapeutics | U.S. Congress | Vaccine
National Academies of Sciences Report Addresses Misinformation About Science
On Dec. 18, 2024, the National Academies of Sciences released a report showing the current information ecosystem makes…
AquaBounty Announced Plans to Cease Fish Farming Operations
On Dec. 11, 2024 the Board of Directors of AquaBounty Technologies announced that the Company was winding down…
Biotechnology | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved AstraZeneca’s Imfinzi for limited-stage small cell lung cancer
On Dec. 4, 2024, The U.S. Food and Drug Administration (FDA) announced approved of AstraZeneca’s blockbuster drug Imfinzi…
Biotechnology | CDC | COVID-19 | Diagnostics | FDA | Infectious Disease | Influenza | Measles | Polio | Vaccine
COVID-19 Vaccination Coverage Among U.S. Adults reported below 20%
On Nov. 21, 2024, the U.S. Centers for Disease Control and Prevention (CDC) reported that by the week…
Biotechnology | CDC | FDA | Genomics | Medical Device | NIH | Non-Profit Research | Oncology | Therapeutics | U.S. Congress
White House Released Report on Growing U.S. Biomanufacturing Capacity for the American Bioeconomy
On Nov. 15, 2024, the White House Office of Science and Technology Policy released a report on Building…
FDA Approved First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
On Nov. 14, 2024, the U.S. Food and Drug Administration approved PTC Therapeutics’ Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated…
Agriculture | Biotechnology | CDC | Diagnostics | FDA | Infectious Disease
FDA Investigation of E. coli outbreak from McDonald’s Onions Completed
On Nov. 13, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control…
Agriculture | Biotechnology | Diagnostics | Environmental | EPA | FDA | Infectious Disease
FDA and EPA Announced First Registered Pre-Harvest Agricultural Water Treatment
On Nov. 4, 2024, the U.S. Food and Drug Administration (FDA), in collaboration with the Environmental Protection Agency…
Biotechnology | Chemical | FDA | NIH | Radiology | Therapeutics
HOPO Therapeutics Awarded Up to $226 Million from BARDA for Advanced Development of its Oral Decorporation Agent for Heavy Metal Toxicity
On Oct. 28, 2024, HOPO Therapeutics announced that it has been awarded a contract valued at up to…
U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease
On Oct. 22, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO® (Respiratory…
Biotechnology | FDA | Influenza | Vaccine
FLUBLOK® (Influenza Vaccine) U.S. label updated with one of Sanofi’s largest flu vaccine safety studies in pregnant individuals
On Oct. 16, 2024, The U.S. Food and Drug Administration (FDA) announced it had updated the label for…
RedHill Biopharma Secured U.S. Government Funding through BARDA to Advance Opaganib for Ebola Treatment
On Oct. 14, 2024, RedHill Biopharma announced that the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA)…
U.S. FDA Approved Pfizer’s HYMPAVZI™ (marstacimab-hncq) for Treatment of Adults and Adolescents with Hemophilia A or B
On Oct. 11, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved HYMPAVZI™ (marstacimab-hncq)…
Biotechnology | Disease | FDA | Oncology | Therapeutics
FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
On Oct. 10, 2024, Genentech announced today that the U.S. Food and Drug Administration (FDA) approved ItovebiTM (inavolisib),…
FDA Approved Arctic apple for commercialization
On Oct. 8, 2024, Okanagan Specialty Fruits® (OSF), the developer and grower behind the innovative Arctic® apple varieties, announced that its…
Biotechnology | Diagnostics | Disease | FDA
FDA Approved Cologuard Plus Test, Setting New Benchmark in Colorectal Cancer Screening
On Oct. 4, 2024, Exact Sciences announced the U.S. Food and Drug Administration (FDA) had approved the Cologuard…
Forecasting the effects of smoking prevalence scenarios on years of life lost and life expectancy
On Oct. 2, 2024, a study from the GBD Tobacco Forecasting Collaborators reported that by accelerating the decline…
FDA Modernization Efforts for Establishing a Unified Human Foods Program launched
On Oct. 1, 2024, the U.S. Food and Drug Administration (FDA) announced that the unified Human Foods Program,…