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…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | 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…
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 | Life Science News | 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…
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…
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…
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…
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…
The FDA issued an EUA to Symbiotica for the COVID-19 self-collected antibody test system
On Apr. 5, 2021, the FDA issued an Emergency Use Authorization (EUA) to Symbiotica for the COVID-19 Self-Collected…
FDA revised Moderna COVID-19 vaccine EUA to increase the number of vaccine doses available
On Apr. 1, 2021, the FDA announced two revisions regarding the number of doses per vial available for…
Moderna provided storage update and FDA authorization for 15-doses per vial of COVID-19 vaccine
On Apr. 1, 2021, Moderna announced that based on submitted stability data, the U.S. Food and Drug Administration…
BD received EUA for asymptomatic screening for SARS-CoV-2 through Serial Rapid Antigen Testing
On Apr. 1, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had granted Emergency…
Quidel’s QuickVue At-Home OTC COVID-19 Test received EUA for screening use with serial testing
On Mar. 31, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA,…
OraSure Technologies submitted COVID-19 rapid antigen prescription home self-test to FDA for EUA
On Mar. 30, 2021, OraSure Technologies announced that it had submitted an application to the U.S. Food and…
Qx Therapeutics received FDA authorization with IND for QXT-101 in phase 2 trial for patients with COVID-19 infection.
On Mar. 30, 2021, Qx Therapeutics announced that the FDA had cleared the companyï¾’s Investigational New Drug application…
Philippines FDA approved the use of leronlimab to treat a COVID-19 patient
On Mar. 29, 2021, CytoDyn announced that the Republic of the Philippines, Department of Health, Food and Drug…
FDA approved first cell-based gene therapy for adult patients with multiple myeloma
On Mar. 27, 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients…
FDA approved first in the world device to treat patients with congenital heart disease
On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) approved the first in the world non-surgical…
FDA approved Bristol Myers Squibbï¾’s and bluebird bioï¾’s Abecma for Relapsed or Refractory Multiple Myeloma
On Mar. 26, 2021, Bristol Myers Squibb and bluebird bio announced that the FDA had approved Abecma (idecabtagene…
AXIM Biotechnologies’ partner Empowered filed EUA with FDA for use of rapid COVID-19 neutralizing antibody test
On Mar. 24, 2021, AXIM Biotechnologies announced that partner Empowered Diagnostics, had filed an Emergency Use Authorization or…