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…
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,…
Biotechnology | Disease | FDA | Neurology | Therapeutics
Amneal Launched CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease
On Sept. 30, 2024, Amneal Pharmaceuticals announced that it had launched CREXONT ® (carbidopa and levodopa) extended-release capsules…
Biotechnology | Diagnostics | FDA | Neurology | Therapeutics
FDA Approved Drug with New Mechanism of Action for Treatment of Schizophrenia
On Sept. 26, 2024, the U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium…
Biotechnology | FDA | Influenza | Vaccine
FDA Approved Nasal Spray Influenza Vaccine for at home use
On Sept. 20, 2024, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is…
FDA Approves Ocrevus Zunovo™ as the First and Only Twice-A-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis
On Sept. 13, 2024, Genentech announced that the U.S. Food and Drug Administration (FDA) had approved Ocrevus Zunovo™…
FDA authorized first OTC hearing aid software to be used in Apple’s AirPods Pro
On Sep. 12, 2024, the the U.S. Food and Drug Administration (FDA) authorized the first over-the-counter (OTC) hearing…
Novavax Formula COVID-19 Vaccine Authorized and Recommended for Use in the U.S.
On Aug. 30, 2024, Novavax announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) had received Emergency Use…
Biotechnology | Disease | FDA | Neurology | Therapeutics
Amneal Received U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease
On Aug. 7, 2024, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved CREXONT…
Biotechnology | Disease | FDA | Neurology | Non-Profit Research | Oncology
FDA Approved Drug Targeting Johns Hopkins-Discovered Brain Cancer Gene Mutation
On Aug. 6, 2024, the U.S. Food and Drug Administration (FDA) announced it had approved vorasidenib (Voranigo, Servier…
Biotechnology | Diagnostics | Disease | FDA | Medical Device | Therapeutics
FDA Approved ‘First Gene Therapy’ to Treat Adults with Metastatic Synovial Sarcoma
On Aug. 2, 2024, the U.S. Food and Drug Administration approved Adaptimmune’s Tecelra (afamitresgene autoleucel), a gene therapy…
FDA Permited Marketing of First Point-of-Care Hepatitis C RNA Test
On Jun. 27, 2024, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert…
Biotechnology | Disease | FDA | Medicine | Therapeutics
FDA Expanded Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
On Jun. 20, 2024, the U.S. Food and Drug Administration expanded the approval of Sarepta Therapeutics’ Elevidys (delandistrogene…
U.S. FDA Approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults
On Jun. 17, 2024, Merck announced that the U.S. Food and Drug Administration (FDA) had approved CAPVAXIVE™ (Pneumococcal…
COVID-19 | FDA | Therapeutics | Vaccine
FDA updated COVID-19 Vaccines for Use in the U.S Beginning in Fall 2024
On Jun. 14, 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend…
Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA EUA
On Jun. 10, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had granted Emergency Use…