RedHill Biopharma received FDA approval for COVID-19 clinical study with opaganib in the U.S.
On May 8, 2020, RedHill Biopharma announced the U.S. Food and Drug Administration (FDA) had approved its Investigational…
Biotechnology | CDC | COVID-19 | FDA
Quidel’s received Emergency Authorization for Rapid Antigen COVID-19 diagnostic assay
On May 8, 2020, Quidel announced it had received Emergency Use Authorization (EUA) from the FDA to market…
OPTI Medical Systems received FDA Emergency Use Authorization for OPTI SARS-CoV-2 RNA PCR test kit for detection of Virus causing COVID-19
On May 7, 2020, OPTI Medical Systems, an IDEXX Laboratories subsidiary announced the U.S. Food and Drug Administration…
PharmaCyte Biotech received medical devices registration and submited pre-EUA application to the FDA for COVID-19 diagnostic kit
On May 6, 2020, PharmaCyte Biotech announced it had received Medical Devices Establishment Registration with the FDAï¾’s Center…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | Oncology | Therapeutics
FDA approved first targeted therapy to treat aggressive form of lung cancer
On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved Tabrecta (capmatinib) for the treatment of…
FDA provided Emergency Use Authorization to PerkinElmer for serological test to identify COVID-19 antibodies
On May 5, 2020, PerkinElmer announced the FDA provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company)…
Organicell announces FDA approval of IND application for treatment of SARS due to COVID-19
On May 5, 2020, Organicell Regenerative Medicine announced the FDA has approved the Investigational New Drug application for…
Diffusion Pharma announced FDA Accelerated Review of TSC clinical development plan to treat COVID-19 patients with ARDS
On May 5, 2020, Diffusion Pharmaceuticals announced the FDA accelerated its review of the Companyï¾’s clinical development plan…
Biotechnology | COVID-19 | FDA
BIOFIRE respiratory panel 21 (RP21) with SARS-CoV-2 obtained FDA Emergency Use Authorization
On May 4, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has…
Vir and Alnylam identified RNAi therapeutic development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for treatment of COVID-19
On May 4, 2020, Vir Biotech and Alnylam Pharma announced announced the selection of a development candidate for…
Cerus announced FDA approval for INTERCEPT Blood System for plasma with alternate plastic disposable kits
On May 4, 2020, Cerus announced FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative…
DNA Genotek’s ORAcollect RNA kit included in EUA granted to Biocerna SARS-CoV-2 test
On May 4, 2020, DNA Genotek, a subsidiary of OraSure Technologies, announced that its ORAcollect RNA kit (OR-100)…
Roche’s COVID-19 antibody test received FDA Emergency Use Authorization and is available in markets accepting the CE mark
On May 2, 2020, Roche announced that the FDA has issued an Emergency Use Authorization for its new…
Gilead announced investigational antiviral remdesivir received FDA Emergency Use Authorization for treatment of COVID-19
On May 1, 2020, Gilead announced the FDA granted emergency use authorization (EUA) for the investigational antiviral remdesivir…
FDA issued Emergency Use Authorization for potential COVID-19 treatment
On May 1, 2020, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir…
FDA approved DARZALEX FASPRO, a new subcutaneous formulation of Daratumumab in treatment of patients with Multiple Myeloma
On May 1, 2020, Janssen Pharma, a Johnson & Johnson company, announced the U.S. Food and Drug Administration…
FDA included ventilator developed by NASA in ventilator Emergency Use Authorization
On Apr. 30, 2020, the FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by…
Chimerix received FDA clearance for rolling submission of New Drug Application for brincidofovir as medical countermeasure for smallpox
On Apr. 28, 2020, Chimerix announced it had received clearance from the FDA for a rolling submission of…
Mateon announced filing of IND with FDA to evaluate antisense drug candidate OT-101 in COVID-19 patients
On Apr. 27, 2020, Mateon Therapeutics announced announced it has submitted an Investigational New Drug application to the…
Neurocrine Biosciences announced FDA approval of ONGENTYS as treatment for patients with Parkinson’s Disease
On Apr. 27, 2020, Neurocrine Biosciences announced the FDA approved once-daily oral ONGENTYS (opicapone) 25 mg and 50…
Moderna announced IND Submitted to FDA for phase 2 study of mRNA vaccine (mRNA-1273) against novel Coronavirus
On Apr. 27, 2020, Moderna announced it had submitted an Investigational New Drug application to the U.S. Food…
Diffusion Pharma announced pre-IND submission to FDA of design for TSC trials to treat Acute Respiratory Distress Syndrome in COVID-19
On Apr. 27, 2020, Diffusion Pharmaceuticals announced the pre-IND submission to the FDA of a planned clinical program…
FDA warns of ‘Off-Label’ use of antimalarial drugs hydroxychloroquine and chloroquine to treat COVID-19 patients
On Apr. 24, 2020, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding known…
ViralClear submits investigational New Drug Application to FDA for phase II clinical trials for merimepodib
On Apr. 24, 2020, BioSig Technologies announced that subsidiary ViralClear had submitted an Investigational New Drug (IND) application…
Baxter obtained FDA Emergency Use Authorization for Oxiris blood purification filter for COVID-19 treatment
On Apr. 23, 2020, Baxter announced it had received emergency use authorization (EUA) from the FDA for the…
The FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen
On Apr. 22, 2020, the FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen…
Caladrius Biosciences planned to assess CLBS119 cell therapy for repair of COVID-19 induced lung damage
On Apr. 23, 2020, Caladrius Biosciences announced the FDA has authorized its investigational new drug application for the…
FDA approved new therapy for triple negative breast cancer that has spread, not responded to other treatments
On Apr. 22, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Immunomedics’ Trodelvy (sacituzumab…
LivaNova permitted to modify cardiopulmonary products’ indications for use to include ECMO therapy to address COVID-19
On Apr. 22, 2020, LivaNova announced that several of its cardiopulmonary products are now permitted to be used…
The FDA approved new therapy for triple negative breast cancer
On Apr. 22, 2020, the FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy), developed by Immunomedics, for the…