Regulation - Approvals

Novavax’s updated Covid-19 vaccine receives FDA emergency use authorisation

Novavax has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its updated Covid-19 vaccine for individuals aged 12 years and over.

Moderna’s RSV vaccine mRESVIA gains EC approval

The European Commission (EC) has granted marketing authorisation for Moderna's mRESVIA (mRNA-1345) vaccine, designed for protecting individuals aged 60 and above from lower respiratory tract disease which is caused by RSV infection.

FDA grants Fast Track Designation to Arthrosi Therapeutics’s AR882 for gout treatment

Arthrosi Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug AR882, aimed at treating gout patients with clinically visible tophi.

EMA validates Type II Variation application for ENHERTU for breast cancer treatment

Daiichi Sankyo has announced that the European Medicines Agency (EMA) validated the Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have previously undergone a minimum of one endocrine therapy in the metastatic setting.

Sandoz’s Enzeevu secures FDA approval for nAMD treatment

The US Food and Drug Administration (FDA) has granted approval for Sandoz's Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar aimed at treating neovascular age-related macular degeneration (nAMD).

US FDA approves Purdue Pharma’s Zurnai auto-injector

The US Food and Drug Administration (FDA) has approved Purdue Pharma’s new drug application for Zurnai, the first nalmefene hydrochloride auto-injector, designed for the emergency treatment of opioid overdose.

Health Canada grants approval for Celltrion’s Steqeyma for multiple conditions

Health Canada has granted approval for Celltrion Healthcare Canada’s Steqeyma (ustekinumab injection) and Steqeyma IV (ustekinumab for injection, solution for intravenous infusion) for treating various chronic inflammatory conditions.

FDA approves Alpha Cognition’s ZUNVEYL for Alzheimer’s treatment

The US Food and Drug Administration (FDA) has approved Alpha Cognition's oral therapy, ZUNVEYL, for the treatment of mild-to-moderate Alzheimer's disease.

US FDA grants RMAT designation for Kyverna’s KYV-101

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Kyverna Therapeutics’ chimeric antigen receptor (CAR) T-cell product candidate, KYV-101 for treating refractory stiff-person syndrome (SPS).