Regulation

SwanBio gets FDA Fast Track designation for adrenomyeloneuropathy therapy

Gene therapy company SwanBio Therapeutics has secured Fast Track designation from the US Food and Drug Administration (FDA) for its AAV-based gene therapy, SBT101, to treat adrenomyeloneuropathy (AMN) patients.

FDA accepts new drug application of Mirati Therapeutics for NSCLC therapy

The US Food and Drug Administration (FDA) has accepted Mirati Therapeutics’ new drug application (NDA) for its therapy adagrasib to treat KRASG12C-mutated non-small cell lung cancer (NSCLC) patients.

US FDA approves Sanofi’s Enjaymo for cold agglutinin disease treatment

The US Food and Drug Administration (FDA) has approved Sanofi’s Enjaymo (sutimlimab-jome) to treat cold agglutinin disease (CAD) in adult patients.

ViiV Healthcare gets FDA nod for two-month dosing of Cabenuva to treat HIV

Specialist HIV company ViiV Healthcare has secured the US Food and Drug Administration (FDA) approval for the expanded labelling of Cabenuva (cabotegravir, rilpivirine) to treat HIV-1 in adults.

Novavax seeks EUA from FDA for Covid-19 vaccine

Novavax has submitted a request seeking emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 vaccine candidate, NVX-CoV2373.

EMA’s CHMP recommends approval for Bristol Myers’s Breyanzi to treat lymphoma

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) to treat several types of lymphoma.

Roche gets FDA priority review for Evrysdi to treat SMA in new-borns

Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) priority review for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in new-borns.

FDA approves Applied Pharmaceutical’s IND application for APS03118

The US Food and Drug Administration (FDA) has approved investigational new drug (IND) application for Applied Pharmaceutical Science’s next generation RET original new drug, APS03118, to treat unlimited cancer types.

Galapagos’ Jyseleca gets UK marketing authorization for ulcerative colitis 

Galapagos has obtained marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Jyseleca (filgotinib 200mg tablets) to treat ulcerative colitis (UC) in Great Britain.