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…
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…
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)…
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…
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…
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | NIH
FDA cleared first COVID-19 home antigen test
On Nov. 9, 2023, the U.S. Food and Drug Administration (FDA) cleared for marketing the first over-the-counter (OTC)…
FDA approved new medication for chronic weight management
On Nov. 8, 2023, the U.S. Food and Drug Administration approved Eli Lilly’s Zepbound (tirzepatide) injection for chronic…
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…
FDA approved Novartis Cosentyx as the first new biologic treatment for hidradenitis suppurativa patients in a decade
On Oct. 31, 2023, Novartis announced that the US Food and Drug Administration (FDA) had approved Cosentyxﾮ (secukinumab)…
FDA approved interchangeable biosimilar for multiple inflammatory diseases
On Oct. 31, 2023, the U.S. Food and Drug Administration (FDA) announced it had approved Amgen’s Wezlana (ustekinumab-auub)…
FDA approved new therapy for rare form of blood cancers called myelodysplastic syndromes
On Oct. 24, 2023, the U.S. Food and Drug Administration approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment…
FDA approved PENBRAYA,the first and only vaccine for prevention of most common serogroups causing meningococcal
On Oct. 20, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved PENBRAYA (meningococcal…
Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | Vaccine
Novavax 2023-2024 COVID-19 Vaccine Authorized and Recommended for Use in the U.S.
On Oct. 3, 2023, Novavax announced that it’s COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) had received Emergency Use…
FDA authorized updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variant
On Oct. 3, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of…
FDA granted first marketing authorization for DNA test to assess predisposition for dozens of cancer types
On Sept. 29, 2023, the U.S. Food and Drug Administration (FDA) granted Invitae de novo marketing authorization for…
FDA launched pilot program to help further accelerate development of rare disease therapies
On Sept. 29, 2023, the U.S. Food and Drug Administration announced it was taking steps to help further…
Amicus Therapeutics announced FDA approval and launch of treatment for Pompe disease
On Sept. 28, 2023, Amicus Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved Pombilitiﾙ…
Agriculture | Biotechnology | FDA | USDA
APHIS issued regulatory status review response for Ohalo Genetics potato
On Sept. 26, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced…
Moderna received U.S. FDA approval for updated COVID-19 vaccine
On Sept. 11, 2023, Moderna announced the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics…