Regulation

FDA clears PDS Biotechnology’s Versamune MUC1 combo for mCRC

The US Food and Drug Administration (FDA) has granted clearance for PDS Biotechnology's investigational new drug (IND) application to assess Versamune MUC1 plus PDS01ADC for the treatment of unresectable, metastatic colorectal carcinoma (mCRC).

Vivus’ Qsymia gains market approval in UAE for obesity treatment

Vivus has received approval in the United Arab Emirates (UAE) to market Qsymia (phentermine and topiramate extended-release capsules) CIV for treating obesity and overweight in adults and paediatric individuals aged 12 and above.

UK MHRA approves Vertex’s Alyftrek for cystic fibrosis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vertex Pharmaceuticals’ triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), for treating cystic fibrosis (CF) in individuals aged six years and above.

FDA approves Celltrion’s biosimilars for various indications

The US Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), the biosimilars referencing Amgen’s Prolia and Xgeva, respectively.

EMA’s CHMP recommends marketing authorisation for Novartis’ Fabhalta

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Novartis' Fabhalta (iptacopan) to treat the adult population with C3 glomerulopathy (C3G).

FDA grants fast track status for Avobis’ AVB-114

The US Food and Drug Administration (FDA) has granted fast track designation for Avobis Bio’s lead therapeutic candidate, AVB-114, for treating Crohn's perianal fistulas.

Health Canada grants marketing authorisation to Kashiv’s Pegfilgrastim

Health Canada has granted marketing authorisation to Kashiv BioSciences’ long-acting G-CSF biosimilar, Pegfilgrastim injection.

US FDA approves Deciphera’s Romvimza for TGCT treatment

The US Food and Drug Administration (FDA) has granted approval for Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat adults with symptomatic tenosynovial giant cell tumour (TGCT).

FDA to review Regeneron’s linvoseltamab BLA for multiple myeloma treatment

The US Food and Drug Administration (FDA) has accepted to review Regeneron Pharmaceuticals’ resubmitted biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory (R/R) multiple myeloma (MM).