Biotechnology | COVID-19 | FDA | 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) had approved mRESVIA (mRNA-1345),…
Biotechnology | Disease | FDA
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 | Disease | FDA | Therapeutics
U.S. FDA Approved Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B
On Apr. 26, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved BEQVEZ™ (fidanacogene…
Agriculture | Biotechnology | Diagnostics | FDA | Infectious Disease | Influenza | Therapeutics | USDA | Vaccine
FDA reported commercial milk supply is safe with investigation of outbreak of HPAI virus ongoing
On Apr. 23, 2024, the U.S. Food and Drug Administration (FDA) announced that nearly all (99%) of the…
Labcorp received FDA Emergency Use Authorization for Mpox PCR test home collection kit
On Apr. 10, 2024, LabCorp announced that the U.S. Food and Drug Administration (FDA) had granted Emergency Use…
FDA approved new antibiotic for three different uses
On Apr. 3, 2024, the U.S. Food and Drug Administration approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for…
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 cobas…
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 (FDA) issued an emergency use authorization for Pemgarda…
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…
Biotechnology | Disease | FDA | Therapeutics
FDA approved first gene therapy for children with metachromatic leukodystrophy
On Mar. 18, 2024, the U.S. Food and Drug Administration (FDA) approved Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), the…
Biotechnology | Disease | FDA | Therapeutics
FDA approved first treatment for patients with liver scarring due to fatty liver disease
On Mar. 14, 2024, the U.S. Food and Drug Administration (FDA) approved Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) for the…
Biotechnology | FDA | Therapeutics | Vaccine
Wegovy received FDA approval for cardiovascular risk reduction in adults with known heart disease or obesity
On Mar. 8, 2024, the U.S. Food and Drug Administration approved a new indication for use of Novo…
Biotechnology | CDC | FDA | Infectious Disease | Influenza | Vaccine
U.S. transitioning to trivalent flu vaccines for 2024-2025
On Mar. 8, 2024, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee…
Biotechnology | Diagnostics | Disease | FDA | Medical Device
FDA cleared first Over-the-Counter continuous glucose monitor
On Mar. 5, 2024, the U.S. Food and Drug Administration (FDA) cleared for marketing the first over-the-counter (OTC)…
Hugel Received FDA Approval in the U.S. of Letybo (letibotulinumtoxinA-wlbg) for Injection for Treatment of Glabellar Lines
On Mar. 4, 2024, Hugel America announced it received U.S. Food and Drug Administration (FDA) approval on its…
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 | Disease | FDA | Therapeutics
FDA approved Xolair as first and only medicine for children and adults with one or more food allergies
On Feb. 16. 2024, Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair…
FDA approved first medication to treat severe frostbite
On Feb. 14, 2024, the U.S. Food and Drug Administration (FDA) approved Eicos Sciences’ Aurlumyn (iloprost) injection to…
Biotechnology | CRISPR | Disease | FDA | 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…
Biotechnology | Disease | FDA | Therapeutics
Swissmedic Authorises CSL’s HEMGENIX® (etranacogene dezaparvovec) as First Gene Therapy for Hemophilia B
On Jan. 15, 2024, CSL announced that Swissmedic had authorised HEMGENIX® (etranacogene dezaparvovec), the first and currently only gene…
FDA authorized Florida’s Drug Importation Program
On Jan. 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s…
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…
Biotechnology | CRISPR | FDA | Genomics | Therapeutics
Vertex and CRISPR Therapeutics announced U.S. FDA approval of CASGEVY for treatment of sickle Cell disease
On Dec. 8, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that the U.S. Food and Drug Administration (FDA)…
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 Fabhaltaﾮ (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 Fabhaltaﾮ (iptacopan)…
Emergent received $75 million contract option from BARDA to procure doses of CYFENDUS (Anthrax Vaccine)
On Nov. 28, 2023, Emergent BioSolutions announced that the Biomedical Advanced Research and Development Authority (BARDA) within the…
Biotechnology | Clinical Research | COVID-19 | FDA | Infectious Disease | Medicine | NIH | Therapeutics | Vaccine
FDA issued final guidance on developing drugs for COVID-19 treatment and preventionﾠ
On Nov. 22, 2023, the U.S. Food and Drug Administration (FDA) issued the final guidance COVID-19: Developing Drugs…
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…