Approvals

FDA approves Onureg as continued treatment for adults in first remission with AML

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.

Gilead gets FDA EUA status for Veklury to also treat patients with moderate Covid-19

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 receives FDA fast track designation for RP-L401 gene therapy for infantile malignant osteopetrosis

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.

GSK gets EC nod for BLENREP to treat relapsed and refractory multiple myeloma

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.

FDA issues EUA for convalescent plasma as potential promising Covid–19 treatment

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 gets FDA nod for Kesimpta to treat relapsing multiple sclerosis

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kesimpta (ofatumumab) to treat relapsing forms of multiple sclerosis (RMS).

New Edition of NSF’s Health Sciences Journal Now Live

This edition of the health sciences Journal is about hope and optimism, and how we must rethink our ways of working.

Chugai’s Enspryng receives regulatory approval from FDA for neuromyelitis optica spectrum disorder

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).

US FDA approves Lampit for the treatment of Chagas disease in children

Bayer announced that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi).