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…
Biotechnology | COVID-19 | FDA | Life Science News | Vaccine
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…
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…
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 CAPVAXIVEâ„¢ (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 CAPVAXIVEâ„¢ (Pneumococcal…
COVID-19 | FDA | Life Science News | 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) has granted Emergency Use…
Biotechnology | COVID-19 | FDA | Life Science News | Vaccine
FDA updated COVID-19 Vaccines for Use in the U.S. Beginning in Fall 2024
On June 5, 2024, the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee announced that it had…
Moderna received U.S. FDA approval for RSV vaccine mRESVIA
On May 31, 2024, Moderna announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345),…
Roche announced FDA approval of HPV self-collection solutions in the U.S. , expanding screening to help eliminate cervical cancer
On May 14, 2024, Roche announced the U.S. FDA approval of its human papillomavirus (HPV) self-collection solution, one…
Biotechnology | Cartoons - Original | COVID-19 | Diagnostics | FDA | Life Science History | Therapeutics | Vaccine
The COVID-19 Vaccine
Cast of Characters: Donald Trump, President | Mike Pence, Vice President | Anthony S. Fauci, MD, Director, National…
Labcorp received FDA Emergency Use Authorization for Mpox PCR test home collection kit
On Apr. 10, 2024, LabCorp announced announced that the U.S. Food and Drug Administration (FDA) had granted Emergency…
Otsuka and Click Therapeutics announce FDA clearance of Rejoyn, first prescription digital therapeutic for MDD
On Apr. 1, 2024, Otsuka Pharmaceutica and Click Therapeutics announced that the U.S. Food and Drug Administration (FDA)…
Roche received FDA approval for the first molecular test to screen for malaria in blood donors
On Mar. 26, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had approved the cobasï¾®…
FDA issued EUA for Pemgarda (pemivibart) for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents
On Mar. 22, 2024, the U.S. Food and Drug Administration the FDA issued an emergency use authorization for…
FDA approved nonsteroidal treatment for Duchenne Muscular Dystrophy
On Mar. 21, 2024, the U.S. Food and Drug Administration (FDA) approved Italfarmaco’s Duvyzat (givinostat) oral medication for…
FDA approved first gene therapy for children with metachromatic leukodystrophy
On Mar. 18, 2024, the U.S. Food and Drug Administration approved Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), the first…
FDA and industry actions end sales of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) used in U.S. food packaging
On Feb. 28, 2024, the U.S. Food and Drug Administration (FDA) announced that grease-proofing materials containing per- and…
Biotechnology | CRISPR | Disease | FDA | Life Science News | Therapeutics
CRISPR Therapeutics announced FDA approval of CASGEVY for treatment of ransfusion-dependent beta thalassemia
On Jan. 16, 2024, the U.S. Food and Drug Administration (FDA) announced it had approved CRISPR Therapeutics’ CASGEVY…
FDA authorized Florida’s Drug Importation Program
On Jan. 5, 2024, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug…
FDA approved first test to help identify elevated risk of developing opioid use disorder
On Dec. 19, 2023, the U.S. Food and Drug Administration approved the first test that uses DNA in…
bluebird bio announced commercial launch of LYFGENIA’ gene therapy for patients ages 12 and older with sickle cell disease
On Dec. 8, 2023, bluebird bio announced the U.S. commercial launch of its LYFGENIA’ (lovotibeglogene autotemcel, also known…
Novartis received FDA approval for Fabhaltaï¾® (iptacopan) as the first oral monotherapy for adults with PNH
On Dec. 5, 2023, Novartis announced that the U.S. Food and Drug Administration (FDA) had approved Fabhaltaï¾® (iptacopan)…
Emergents received $75 million contract option from BARDA to procure doses of CYFENDUSï¾™ (Anthrax Vaccine)
On Nov. 28, 2023, Emergent BioSolutions announced that the Biomedical Advanced Research and Development Authority (BARDA) within the…
FDA issued final guidance on developing drugs for COVID-19 treatment and preventionï¾
On Nov. 22, 2023, the U.S. Food and Drug Administration issued the final guidance COVID-19: Developing Drugs and…
Masimo W1 Medical Watch received FDA 510(k) clearance for over-the-counter and prescription Use
On Nov. 17, 2023, Masimo announced that the Masimo W1 medical watch has received FDA 510(k) clearance for…
FDA granted Marketing Authorization of first test for chlamydia and gonorrhea with at-home sample collection
On Nov. 15, 2023, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple…
FDA cleared first COVID-19 home antigen test
On Nov. 9, 2023, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen…
Abbott received FDA approval for HPV test to run on Alinity m family of diagnostic assays
On Nov. 2, 2023, Abbott announced that it had received U.S. Food and Drug Administration (FDA) approval for…