Gilead Sciences has secured expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) to treat not only hospitalised patients suffering from severe COVID-19, but also those who were moderately afflicted.
Rocket Pharmaceuticals, a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to RP-L401, the Company’s lentiviral vector (LVV)-based gene therapy for the treatment of Infantile Malignant Osteopetrosis (IMO), a rare, severe monogenic bone resorption disorder characterized by skeletal deformities, neurologic abnormalities and bone marrow failure.
HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of Covid-19 patients.
GlaxoSmithKline (GSK) has secured conditional marketing authorisation from the European Commission (EC) for its BLENREP (belantamab mafodotin) to treat patients with relapsed and refractory multiple myeloma.
Exelixis announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC).
The US Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kesimpta (ofatumumab) to treat relapsing forms of multiple sclerosis (RMS).
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
This edition of the health sciences Journal is about hope and optimism, and how we must rethink our ways of working.
Chugai Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has approved the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody, Enspryng (US generic name: satralizumab-mwge) (hereafter, Enspryng) created by Chugai for the treatment of adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
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