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 AdCOVIDï¾™ IND application
On Feb. 17, 2021, Altimmune announced that the FDA had cleared the Companyï¾’s Investigational New Drug (IND) application…
Meridian provided an update on the Revogeneï¾® SARS-CoV-2 EUA submission
On Feb. 16, 2021, Meridian Bioscience provided an update on its application for Emergency Use Authorization (EUA) with…
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 FDA had granted Emergency Use Authorization (EUA) for…
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…
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 FDA to a…
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 VBIï¾’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…
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…
FDA approved Aurinia Pharmaceuticalsï¾’ LUPKYNISï¾™ (voclosporin) for adults with active lupus nephritis
On Jan. 22, 2021, Aurinia Pharmaceuticals announced that the FDA had approved LUPKYNISTM (voclosporin) in combination with a…
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 Janssenï¾’s rilpivirine and ViiV…
Adamis Pharmaceuticals announced IND Submission to FDA for Tempol for the treatment of COVID-19
On Jan. 19, 2021, Adamis Pharma announced the submission of an Investigational New Drug (IND) to FDA for…
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)…
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…
PerkinElmer SARS-CoV-2 RT-PCR assay received FDA EUA for asymptomatic testing
On Jan. 14, 2021, PerkinElmer announced that its PerkinElmerï¾® Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization…
FDA accepted for Priority Review the BLA for V114, Merckï¾’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 BinaxNOWï¾™ 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,…
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 | Life Science News | 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…
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the FDA approved the first generic of glucagon for injection USP, 1 mg/vial packaged…
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 AdCOVIDï¾™ clinical trial
On Dec. 23, 2020, Altimmune announced that the FDA had issued a clinical hold on the Companyï¾’s Investigational…
Sorrento announced it had submitted an EUA application to the FDA for COVI-STIX rapid test for detection of SARS-CoV-2 antigen
On Dec. 22, 2020, Sorrento Therapeutics announced that an Emergency Use Authorization (EUA) Application had been submitted to…