U.S. FDA authorized an EUA for the Janssen COVID-19 vaccine manufacture at Emergent facility
On Jul. 2, 2021, the Food and Drug Administration (FDA) authorized the use, under the emergency use authorization…
Meridian resubmitted application to FDA for Emergency Use Authorization for Revogeneï¾® SARS-CoV-2 molecular assay
On Jun. 28, 2021, Meridian Bioscience announced that it had re-submitted its application for Emergency Use Authorization (EUA)…
Rocheï¾’s Actemra/RoActemra received FDA EUA for treatment of COVID-19 in hospitalised adults and children
On Jun. 25, 2021, Roche announced that the Food and Drug Administration (FDA) has issued an Emergency Use…
Eisai and Biogen announced FDA granted Breakthrough Therapy Designation for Lecanemab for treatment of Alzheimer’s disease
On Jun. 23, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted…
Emergent BioSolutions’ COVID-19 vaccine drug substance authorized as part of Johnson & Johnson EUA
On Jun. 11, 2021, Emergent BioSolutions announced that two batches of COVID-19 vaccine manufactured by at its Baltimore…
Quidel received amended Emergency Use Authorization for new Sofia Q rapid antigen test device
On Jun. 11, 2021, Quidel announced it had received an amended Emergency Use Authorization (EUA) from the U.S….
FDA issued EUA for the Janssen COVID-19 vaccine manufactured at Emergent BioSolutions facility in Baltimore
On Jun. 11, 2021, The FDA issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two…
Moderna filed for Emergency Use Authorization for its COVID-19 vaccine in adolescents in the United States
On Jun. 10, 2021, Moderna announced that it had requested an emergency use authorization (EUA) for its COVID-19…
Vertex announces FDA approval for TRIKAFTAï¾® in children with Cystic Fibrosis ages 6 through 11 with certain mutations
On Jun. 9, 2021, Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved expanded use of…
FDA granted accelerated approval for ADUHELMï¾™ as the first and only Alzheimerï¾’s disease treatment
On Jun. 7, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted…
OraSure Technologies receives three EUA’s for its COVID-19 rapid antigen tests for non-prescription use
On Jun. 7, 2021, OraSure Technologies announced that it had received Emergency Use Authorization (EUA) from the FDA…
FDA approved new rug treatment for chronic weight management, first since 2014
On Jun. 4, 2021, the U.S. Food and Drug Administration announced it had approved Novo Nordisk’s Wegovy (semaglutide)…
Chimerix received U.S. FDA approval for TEMBEXAï¾® (brincidofovir) for treatment of smallpox
On Jun. 4, 2021, Chimerix announced that the U.S. Food and Drug Administration (FDA) had granted TEMBEXAï¾® (brincidofovir)…
FDA authorized lower 1,200 mg intravenous and subcutaneous dose of REGEN-COV antibody cocktail to treat COVID-19 patients
On Jun. 4, 2021, Regeneron announced the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization…
Innovation Pharma completed enrollment in phase 2 clinical trial for COVID-19
On Jun. 3, 2021, Innovation Pharma announced that it had achieved full patient enrollment in its randomized, double-blind,…
Relief Therapeutics reported that NRx Pharma, had submitted an application for EUA for Aviptadil to the U.S. FDA
On Jun. 2, 2021, RELIEF THERAPEUTICS reported that its collaboration partner, NRx Pharmaceuticals, announced that it had submitted…
FDA approved LUMAKRAS for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
On May 28, 2021, Amgen announced that the FDA had approved LUMAKRAS (sotorasib) for the treatment of adult…
Humanigen submitted application to FDA for Emergency Use Authorization for lenzilumab in COVID-19
On May 28, 2021, Humanigen announced that the company had submitted an application to the FDA requesting Emergency…
GSK and Vir Biotech announced sotrovimab (VIR-7831) received EUA from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients
On May 26, 2021, GlaxoSmithKline and Vir Biotechnology announced the U.S. Food and Drug Administration (FDA) granted an…
FDA approved first targeted therapy for subset of non-mmall cell lung cancer
On May 21, 2021, the FDA approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small…
InBios received FDA EUA for COVID-19 POC antigen detection test
On May 12, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
InBios received FDA EUA for COVID-19 POC antigen detection test
On May 12, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
FDA granted Fast Track Designation to CERC-002 for treatment of hospitalized patients with COVID-19
On May 10, 2021, Cerecor announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…
Pfizer and BioNTech received first U.S. EUA of COVID-19 vaccine in adolescents
On May 10, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
COVID-19 | FDA | Life Science News | Vaccine
Pfizer and BioNTech initiated rolling submission of Biologics License Application for FDA approval of COVID-19 vaccine
On May 7, 2021, Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the…
Precipio launched Rapid COVID-19 Antibody test on Amazon platform
On May 3, 2021, Precipio announced that it had successfully launched its COVID-19 rapid antibody test (20 minute)…
FDA approved treatment for chronic kidney disease
On Apr. 30, 2021, the FDA approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney…
FDA revoked the EUA of the Battelle CCDS Critical Care Decontamination System
On Apr. 30, 2021, the FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care…
FDA completed inspection of Emergent BioSolutions vaccine production facility
On Apr. 21, 2021, the FDA announced that it had completed an inspection of the Emergent BioSolutions and…
FDA approved first immunotherapy for initial treatment of gastric cancer
On Apr. 16, 2021, the FDA approved Bristol-Myers Squibb’ s Opdivo (nivolumab), in combination with certain types of…