Regulation

AbbVie seeks FDA approval for non-small cell lung cancer treatment

AbbVie has filed a biologics license application (BLA) with the US Food and Drug Administration (FDA) seeking accelerated approval for telisotuzumab vedotin (Teliso-V) in adult non-small cell lung cancer (NSCLC) patients.

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).

EMA CHMP recommends AbbVie’s mirvetuximab soravtansine for ovarian cancer

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AbbVie’s mirvetuximab soravtansine in adults with a specific type of ovarian cancer.

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.

Moderna’s updated Covid-19 vaccine receives positive EMA CHMP opinion

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided positive opinion for Moderna's updated Covid-19 vaccine, Spikevax, which specifically targets the SARS-CoV-2 variant JN.1.

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.

Skyline Therapeutics secures FDA orphan drug status for RP therapy

Skyline Therapeutics has announced that the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) to its gene therapy, SKG1108, for the treatment of Retinitis Pigmentosa (RP), an inherited retinal disease.

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.

Zuellig Pharma and Regeneron sign deal to supply Libtayo in South Korea and Taiwan

Zuellig Pharma has entered into an exclusive distribution agreement with Regeneron Ireland DAC for the launch and commercialisation of Libtayo (cemiplimab) in the South Korean and Taiwanese markets.