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…
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…
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 cobasﾮ…
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…
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…
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…
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…