FDA approved Trelegy Ellipta as first once-daily single inhaler triple therapy for treatment of both asthma and COPD in the U.S.
On Sept. 10, 2020, GlaxoSmithKline and Innoviva announced the U.S. Food and Drug Administration (FDA) had approved a…
INOVIO added Thermo Fisher Scientific to global manufacturing consortium
On Sept. 8, 2020, INOVIO announced that Thermo Fisher Scientific, the world leader in serving science, had signed…
Biotechnology | COVID-19 | FDA
OraSure’s ORAcollect-RNA device Included in EUA granted to MiraDx for SARS-CoV-2 test
On Sept. 3, 2020, OraSure Technologies announced that its ORAcollect-ﾷRNA (OR-100) collection device was included along with other…
Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 & influenza A/B test for use on cobas 6800/8800 systems
On Sept. 3, 2020, Roche announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the…
COVID-19 | Disease | FDA | Therapeutics
City of Hope doctors lead novel clinical trial to treat cancer patients with COVID-19
On Sept. 1, 2020, City of Hope announced that it was investigating an innovative treatment for cancer patients…
Roche received FDA approval for first HIV-1/HIV-2 Qualitative test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
On Sept. 1, 2020, Roche announced FDA approval for the cobasﾮ HIV-1/HIV-2 Qualitative Test for use on the…
T2 Biosystems received FDA Emergency Use Authorization for COVID-19 molecular diagnostic test
On Aug. 31, 2020, T2 Biosystems announced that the FDA had issued an Emergency Use Authorization (EUA) for…
FDA expanded Emergency Use Authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19
On Aug. 28, 2020, the FDA issued an emergency use authorization (EUA) to Yale School of Public Health…
Gileadﾒs investigational antiviral Vekluryﾮ (remdesivir) received FDA Emergency Use Authorization for treatment of patients with moderate COVID-19
On Aug. 28, 2020, Gilead Sciences announced the FDA expanded the Emergency Use Authorization (EUA) enabling use of…
Laurent Pharmaceuticals received FDA approval to initiate its COVID-19 phase 2 clinical trial in the U.S.
On Aug. 27, 2020, Laurent Pharmaceuticals announced that it had received approval from the U.S. Food and Drug…
Abbott’s fast, $5, 15-minute, easy-to-use COVID-19 antigen test for healthcare professionals received FDA Emergency Use Authorization
On Aug. 26, 2020, Abbott announced the FDA had issued Emergency Use Authorization (EUA) for its BinaxNOWﾙ COVID-19…
Biotechnology | COVID-19 | FDA | Therapeutics
XBiotech announced COVID-19 candidate therapy
On Aug. 24, 2020, XBiotech announced that the U.S. Food and Drug Administration (FDA) issued an emergency use…
FDA issued Emergency Use Authorization for convalescent plasma as potential promising COVIDﾖ19 treatment
On Aug. 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the…
Mayo Clinic discontinued enrollment in Expanded Access Program for convalescent plasma with FDA Emergency Use Authorization
On Aug. 23, 2020, the Mayo Clinic announced that with the FDA Emergency Use Authorization of convalescent plasma,…
Accelerate Diagnostics announced FDA Emergency Use Authorization for COVID-19 antibody testing system
On Aug. 19, 2020, Accelerate Diagnostics and BioCheck announced that the FDA had issued an Emergency Use Authorization…
FDA approved teatment for rare disease affecting optic nerves, spinal cord
On Aug. 17, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Enspryng (satralizumab-mwge) for the treatment…
FDA issued Emergency Use Authorization to Yale School of Public Health for SalivaDirect method of saliva sample processing
On Aug. 15, 2020, the FDA issued an emergency use authorization (EUA) to Yale School of Public Health…
Quick and affordable saliva-based COVID-19 test developed by Yale scientists received FDA Emergency Use Authorization
On Aug. 15, 2020, a saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public…
Baxter obtained FDA Emergency Use Authorizations for HF20 set and ST set used in CRRT during Covid-19 pandemic
On Aug. 12, 2020, Baxter announced it had received Emergency Use Authorizations (EUAs) from the FDA for the…
FDA approved targeted treatment for rare Duchenne Muscular Dystrophy mutation
On Aug. 12, 2020, the FDA granted accelerated approval to NS Pharma’s Viltepso (viltolarsen) injection for the treatment…
Hologic launched validated pooling protocol for COVID-19 testing
On Aug. 11, 2020, Hologic announced that it has validated use of its Aptimaﾮ and Panther Fusionﾮ molecular…
COVID-19 | FDA | Therapeutics
Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19
On Aug. 10, 2020, Gilead Sciences announced that it had submitted a New Drug Application (NDA) to the…
Vaxart announced IND filed for COVID-19 vaccine
On Aug. 10, 2020, Vaxart announced that its COVID-19 Investigational New Drug (IND) application has been filed with…
Humanigen expands phase III study of lenzilumab in COVID-19 to Brazil
On Aug. 10, 2020, Humanigen announced that the Brazilian regulatory agency, Anvisa, had granted permission to commence a…
Biotechnology | Disease | FDA | Therapeutics
FDA approved oral treatment for spinal muscular atrophy
On Aug. 7, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Evrysdi (risdiplam) to treat patients…
FDA approved two emergency INDs for COVID-19 outpatient therapy
On Aug. 6, 2020, Organicell Regenerative Medicine announced that the FDA had approved two outpatient Emergency Investigational New…
Johnson & Johnson announces agreement with US Government for 100 million doses of investigational COVID-19 vaccine
On Aug. 5, 2020, Johnson & Johnson announced a $1 billion agreement with the U.S. government for the…
Biotechnology | COVID-19 | Diagnostics | FDA
Precipio launched Covid-19 antibody test in its CLIA laboratory
On Aug. 4, 2020, Precipio announced it had completed the internal validation of the U.S. Food and Drug…
FDA issued Emergency Use Authorization for Impella heart pumps to provide unloading therapy to COVID-19 patients
On Aug. 4, 2020, Abiomed announced the FDA had issued an emergency use authorization (EUA) for its left-sided…
FDA approved new indication for drug containing an active Cannabis ingredient to treat seizures in rare genetic disease
On Jul. 31, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Epidiolex (cannabidiol) [CBD]…