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 TRIKAFTAﾮ 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…
RECOVERY trial found aspirin does not improve survival for patients hospitalised with COVID-19
On Jun. 8, 2021, the University of Oxford announced that the RECOVERY trial found aspirin does not improve…
Biotechnology | Disease | FDA | Neurology | Therapeutics
FDA granted accelerated approval for ADUHELM as the first and only Alzheimer’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…
Chimerix received U.S. FDA approval for TEMBEXAﾮ (brincidofovir) for treatment of smallpox
On Jun. 4, 2021, Chimerix announced that the U.S. Food and Drug Administration (FDA) had granted TEMBEXAﾮ (brincidofovir)…
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)…
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…
AquaBounty received approval for the sale of GE Atlantic Salmon in Brazil
On Jun. 1, 2021, AquaBounty Technologies announced the regulatory approval of the Company’s GE Atlantic salmon by Brazil’s…
Moderna announced rolling submission of Biologics License Application with FDA for COVID-19 vaccine
On Jun. 1, 2021, Moderna announced that it had initiated the rolling submission process with the U.S. Food…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
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 U.S. Food and Drug Administration (FDA) had approved LUMAKRAS (sotorasib)…
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…
Biotechnology | Diagnostics | FDA | Infectious Disease | NIH | Therapeutics
NIAID scientists found that Salmonella use intestinal epithelial cells to colonize the gut
On May 26, 2021, National Institutes of Health (NIH) scientists reported that the immune system’s attempt to eliminate…
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…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved first targeted therapy for subset of non-small cell lung cancer
On May 21, 2021, the the U.S. Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) as the first…
Biotechnology | COVID-19 | Diagnostics | FDA
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…
Biotechnology | COVID-19 | Diagnostics | FDA
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…
AquaBounty sold out first commercial harvest of genetically engineered Atlantic Salmon from its Indiana farm
On May 10, 2021, AquaBounty Technologies announced that purchase orders had been received for the planned harvest of…
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…
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…
Biotechnology | COVID-19 | Diagnostics | FDA
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…
FDA revoked Emergency Use Authorization for monoclonal antibody bamlanivimab
On Apr. 16, 2021, the FDA revoked the emergency use authorization (EUA) that allowed for Eli Lilly’s investigational…
FDA authorized new high-throughput, automated system for leading COVID-19 test
On Apr. 12, 2021, Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) had granted…