Regulation

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.

ReViral secures FDA fast track status for sisunatovir to treat severe RSV infection

Clinical-stage biopharmaceutical company ReViral has secured fast track designation from the US Food and Drug Administration (FDA) for its sisunatovir to treat patients with serious respiratory syncytial virus (RSV) infection.

FDA approves IND for PSC’s stem cell therapy candidate for Covid-19

Calidi Biotherapeutics said that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.

French prosecutors file charges against Sanofi over epilepsy drug Depakine

Pharmaceutical firm Sanofi is being investigated by French prosecutors for manslaughter over birth defects associated with an epilepsy drug Depakine.

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.