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The U.S. Food and Drug Administration granted Emergency Use Authorization for Mammoth Biosciences Inc.’s DETECTR BOOST SARS-CoV-2 Reagent Kit, a first of its kind high-throughput solution that combines the power of CRISPR with laboratory automation for SARS-CoV-2 testing.
Prellis Biologics entered into a multi-target drug discovery collaboration and licensing agreement with Bristol Myers Squibb utilizing the Bay Area biotechnology company’s first-in-class externalized human immune system (EXIS) based on human lymph node organoids (LNO).
Award-winning creative executive Collette Douaihy was named Chief Creative Officer for dentsu health. In this role, Douaihy is dedicated to inspiring agency partners and clients to think big, bravely, and boldly in an ever-changing healthcare market.
The U.S. Food and Drug Administration approved Xeris Biopharma Holdings Inc.’s Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test, providing nationwide access to a new at-home or over-the-counter self-test as Covid-19 testing needs continue to grow for individuals, families and businesses.
Cyrus Biotechnology announced that the Seattle-based biotechnology firm’s pre-clinical stage COVID therapeutic lead molecule, ACE2.v2.4 strongly binds the spike protein of SARS-CoV-2 variant of concern (VOC) omicron.
The U.S. Food and Drug Administration authorized the emergency use of Pfizer Inc.’s Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced Conditional Marketing Authorization (CMA) of RYBREVANT (amivantamab) for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.
Reata Pharmaceuticals Inc. announced the outcome of the U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting on bardoxolone methyl for the treatment of patients with chronic kidney disease caused by Alport syndrome.
Merck announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL) – a nucleoside reverse transcriptase translocation inhibitor – for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection.
