Regulation

Imfinzi granted FDA priority review for less-frequent, fixed-dose use

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.

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).

Gilead seeks FDA approval for Veklury in Covid-19 treatment

Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) seeking its approval for the treatment of Covid-19.

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.