Agilent announced immunoassay kit to detect SARS-CoV-2 antibodies
On Feb. 18, 2021, Agilent Technologies announced the launch of the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay…
Altimmune announced FDA clearance of AdCOVIDﾙ IND application
On Feb. 17, 2021, Altimmune announced that the FDA had cleared the Companyﾒs Investigational New Drug (IND) application…
Meridian provided an update on the Revogeneﾮ SARS-CoV-2 EUA submission
On Feb. 16, 2021, Meridian Bioscience provided an update on its application for Emergency Use Authorization (EUA) with…
COVID-19 | Diagnostics | FDA | Medical Device
BD announced EUA, CE Mark for combination molecular diagnostic to detect SARS-CoV-2, influenza A+B in single test
On Feb. 12, 2021, BD (Becton, Dickinson) announced that the U.S. Food and Drug Administration (FDA) had granted…
ImmunityBio and NantKwest announced FDA authorization to study hAd5 T-cell COVID-19 vaccine
On Feb. 11, 2021, ImmunityBio and NantKwest announced they had received FDA authorization to expand Phase I testing…
Qatar Ministry of Public Health issued Emergency Use Authorization for COVID-19 Vaccine Moderna
On Feb. 11, 2021, Moderna announced that the Qatar Ministry of Public Health had issued an emergency use…
Tonix Pharmaceuticals to develop COVID-19 skin test to measure SARS-CoV-2 exposure and T cell immunity
On Feb. 8, 2021, Tonix Pharmaceuticals announced it had received the written response from the U.S. Food and…
FDA approved new treatment for adults with relapsed or refractory large-B-Cell lymphoma
On Feb. 5, 2021, the FDA approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients…
VBI Vaccines announced FDA Acceptance of BLA filing for VBIﾒs 3-antigen prophylactic hepatitis B vaccine
On Feb. 2, 2021, VBI Vaccines announced that the FDA had accepted its filing of the Biologics License…
Biotechnology | COVID-19 | FDA
Precipio launched COVID-19 antibody testing at point-of-care
On Jan. 28, 2021, Precipio announced that following receipt of an Emergency Use Authorization from the U.S. Food…
Nirmidas Biotech received FDA Emergency Use Authorization for its COVID-19 rapid antibody fingerstick test
On Jan. 25, 2021, Nirmidas Biotech announced its second FDA Emergency Use Authorization (EUA) for their COVID-19 rapid…
Biotechnology | Cardiology | Disease | FDA | Therapeutics
FDA approved Aurinia Pharmaceuticals LUPKYNIS (voclosporin) for adults with active lupus nephritis
On Jan. 22, 2021, Aurinia Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved LUPKYNISTM…
FDA approved first extended-release, injectable drug regimen for adults living with HIV
On Jan. 21, 2021, the FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for…
Janssen announced FDA approval of CABENUVA, the first long-acting HIV treatment regimen
On Jan. 21, 2021, Janssen Pharmaceutical announced the FDA had approved CABENUVA (consisting of Janssenﾒs rilpivirine and ViiV…
Mesa Biotech received 510(k) clearance and CLIA waiver for Its Accula Strep A Molecular Point of Care Test
On Jan. 19, 2021, Mesa Biotech announced it had received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA)…
PerkinElmer SARS-CoV-2 RT-PCR assay received FDA EUA for asymptomatic testing
On Jan. 14, 2021, PerkinElmer announced that its PerkinElmerﾮ Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization…
Innovation Pharma’s Brilacidin for the treatment of COVID-19 received FDA Fast Track Designation
On Jan. 14, 2021, Innovation Pharmaceuticals announced that the FDA had designated as a Fast Track development program…
FDA accepted for Priority Review the BLA for V114, Merckﾒs investigational 15-valent pneumococcal conjugate vaccine
On Jan. 12, 2021, Merck announced the FDA accepted for priority review a Biologics License Application (BLA) for…
Abbott announced fulfillment of Federal government purchase of 150 million BinaxNOWﾙ COVID-19 Rapid Tests
On Jan. 12, 2021, Abbott announced it had received FDA 510(k) clearance for the first rapid handheld traumatic…
Abbott received CE Mark for its COVID-19 IgG quantitative antibody blood test
On Jan. 11, 2021, Abbott announced it had received FDA 510(k) clearance for the first rapid handheld traumatic…
FDA conditionally approved first oral tablet to treat lymphoma in dogs
On Jan. 11, 2021, the FDA conditionally approved Anivive Lifesciences’ Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma,…
Biotechnology | CRISPR | FDA | Therapeutics
FDA cleared initiation of the Editas Medicine’s EDIT-301 clinical trial using CRISPR/Cas12a gene editing
On Jan. 11, 2021, Editas Medicine announced the U.S. Food and Drug Administration (FDA) had cleared the initiation…
Humanigen announced CRADA agreement with US government to develop lenzilumab for COVID-19
On Jan. 10, 2021, Humanigen announced that they were partnering to make lenzilumab available to hospitalized and hypoxic…
FDA issued alert regarding SARS-CoV-2 viral mutation to health care providers and clinical laboratory staff
On Jan. 8, 2021, the FDA alerted clinical laboratory staff and health care providers that it was monitoring…
FDA announced statement on authorized dosing schedules for COVID-19 vaccines
On Jan. 4, 2021, the FDA announced that the two different mRNA vaccines were shown remarkable effectiveness of…
Biotechnology | COVID-19 | FDA | NIH | Therapeutics
Medigen Vaccines obtained TFDA phase 2 IND approval for COVID19 vaccine
On Dec. 30, 2020, Medigen Vaccine Biologics announced that it had obtained TFDA Phase 2 IND approval of…
Biotechnology | Disease | FDA | Therapeutics
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the U.S. Food and Drug Administration approved the first generic of glucagon for injection…
Merck announced agreement with US Government for doses of Investigational biological therapy for COVID-19 patients
On Dec. 23, 2020, Merck announced an agreement with the U.S. Government to support the development, manufacture and…
Biotechnology | COVID-19 | FDA
Quidel received EUA for moderately complex Solana SARS molecular test for COVID-19 diagnosis
On Dec. 23, 2020, Quidel announced that it had received Emergency Use Authorization (EUA) from the FDA to…
Altimmune provided an update on investigational New Drug Application for phase 1 AdCOVIDﾙ clinical trial
On Dec. 23, 2020, Altimmune announced that the FDA had issued a clinical hold on the Companyﾒs Investigational…