Regulation

Japan MHLW grants orphan drug status to Renalys’ sparsentan for IgAN treatment

The Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted orphan drug designation to Renalys Pharma’s sparsentan, which is intended for the treatment of primary IgA nephropathy (IgAN).

China’s NMPA grants marketing approval to Kelun-Biotech’s sac-TMT for TNBC treatment

The China’s National Medical Products Administration (NMPA) has granted marketing authorisation to Sichuan Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (sac-TMT), a domestically developed trophoblast cell surface antigen 2 (TROP-2)-directed antibody-drug conjugate (ADC) for the treatment of the adult population with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).

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).

Neuvivo files NDA seeking FDA approval for ALS treatment

Neuvivo has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) seeking approval for its investigational treatment NP001for treating amyotrophic lateral sclerosis (ALS).

FDA grants priority review for AstraZeneca’s Calquence sNDA

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).

FDA grants fast track status for Volastra’s VLS-1488 to treat ovarian cancer

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).

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).

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).