Regulation

Takeda receives FDA approval for Vonvendi sBLA

Takeda Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) of an expanded indication for Vonvendi, for routine prophylaxis in adults with von Willebrand disease (VWD), including Types 1 and 2.

FDA grants breakthrough therapy status to Eli Lilly’s olomorasib

Eli Lilly has received the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to olomorasib, an investigational KRAS G12C inhibitor.

EMA grants orphan designation to Aldeyra’s ADX-2191 for vitreoretinal lymphoma

Aldeyra Therapeutics has secured orphan designation from the European Medicines Agency (EMA) for ADX-2191, an intravitreal injection of methotrexate, intended for primary large B-cell lymphomas in immune-privileged sites, such as primary vitreoretinal lymphoma.

FDA grants orphan status for AlzeCure’s pain drug candidate

The US Food and Drug Administration (FDA) has granted orphan drug designation for AlzeCure Pharma’s pain drug candidate, ACD440.

Innovent’s Mazdutide receives approval for chronic weight management in China

Innovent Biologics has received the National Medical Products Administration (NMPA) of China’s approval for mazdutide for chronic weight management in adults with obesity or overweight.

CHMP endorses ExCellThera’s stem cell transplantation product

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for ExCellThera's cryopreserved haematopoietic stem cell transplantation product, Zemcelpro.

Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab

Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).

Ferrer’s progressive supranuclear palsy therapy gains FDA fast track status

Ferrer's FNP-223 has secured fast-track designation from the US Food and Drug Administration (FDA), intended to slow down the development of progressive supranuclear palsy (PSP), a neurodegenerative disease.

FDA grants fast-track status to SolasCure’s gel for calciphylaxis ulcers

The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.