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…
-
-
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…
-
WHO listed additional COVID-19 vaccine for emergency use and issues interim policy recommendations
On May 7, 2021, the World Health Organization (WHO) listed the Sinopharm COVID-19 vaccine for emergency use, giving…
-
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…
-
Biotechnology | Clinical Research | COVID-19 | FDA | HIV | Infectious Disease | Oncology | Therapeutics
CytoDyn executed agreement with Chiral Pharma to provide up to 200,000 vials of leronlimab to Philippines
On Apr. 15, 2021, CytoDyn announced it had executed an exclusive supply and distribution agreement with Chiral Pharma…
-
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 U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of…
-
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…
-
Biotechnology | COVID-19 | Diagnostics | FDA
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 U.S….
-
Biotechnology | COVID-19 | Diagnostics | FDA | Vaccine
Abbott’s BinaxNOW™ Rapid Antigen Self Test Receives FDA Emergency Use Authorization for Asymptomatic, OTC, Non-Prescription, Multi-Test Use
On Mar. 31, 2021, Abbott announced it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization…
-
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 company’s Investigational New Drug application…
-
BD announced FDA Emergency Use Authorization for combination COVID-19, flu rapid antigen test
On Mar. 30, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) granted emergency use…
-
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…
-
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…
-
Biotechnology | FDA | Oncology | Therapeutics
FDA approved first cell-based gene therapy for adult patients with multiple myeloma
On Mar. 27, 2021, the U.S. Food and Drug Administration (FDA) announced it had approved Abecma (idecabtagene vicleucel),…
-
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…
-
Biotechnology | FDA | Oncology | Therapeutics
FDA approved Bristol Myers Squibb’s and bluebird bio’s Abecma for Relapsed or Refractory Multiple Myeloma
On Mar. 26, 2021, Bristol Myers Squibb and bluebird bio announced that the U.S. Food and Drug Administration…
-
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…
-
FDA issued an EUA to the Twist Bioscience for their SARS-CoV-2 NGS assay.
On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to…
-
Cepheid received Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
On Mar. 21, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
-
FDA authorized first machine learning-based screening device to identify COVID-19 infection biomarkers
On Mar. 19, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the…
-
FDA permitted marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
On Mar. 17, 2021, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory…
