The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).
The US Food and Drug Administration (FDA) has granted fast track designation for Volastra Therapeutics’ KIF18A inhibitor, VLS-1488, to treat patients with platinum-resistant high-grade serous ovarian cancer (HGSOC).
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).
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 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).
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.
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.
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.
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 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.
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