Approvals

Volixibat gains FDA breakthrough therapy designation

Mirum Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its drug candidate, volixibat, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).

FDA grants approval for Fresenius-Formycon’s biosimilar Otulfi

The US Food and Drug Administration (FDA) has granted approval for Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz), a ustekinumab biosimilar to the reference medicine Stelara (ustekinumab).

Amgen’s TEPEZZA gets Japan’s MHLW approval for thyroid eye disease treatment

Amgen has announced the receipt of approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for TEPEZZA (Teprotumumab) to treat active or high clinical activity score (CAS) thyroid eye disease (TED).

China NMPA approves Keymed Biosciences’ Stapokibart for atopic dermatitis

The National Medical Products Administration (NMPA) of China has approved Keymed Biosciences’ new drug application granting marketing approval for Stapokibart to treat adults with moderate-to-severe atopic dermatitis.

UK MHRA grants authorisation for Moderna’s updated Covid-19 vaccine

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation for Moderna’s Spikevax JN.1, an updated Covid-19 vaccine targeting the JN.1 variant of SARS-CoV-2.

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.