Approvals

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).

Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy

Roche has secured approval from the US Food and Drug Administration (FDA) for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in adults and children aged two months of age and older.

ViiV Healthcare gets FDA expanded approval for HIV-1 drug Dovato

Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) as a complete regimen to treat HIV-1 infection.

GSK secures FDA nod for BLENREP to treat relapsed or refractory multiple myeloma

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its BLENREP (belantamab mafodotin-blmf) to treat patients with relapsed or refractory multiple myeloma.

MYR Pharmaceuticals receives conditional marketing authorisation by European Commission for HEPCLUDEX

MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that the European Commission (EC) has granted the Conditional Marketing Authorization (CMA) for their lead compound HEPCLUDEX.