Regulation

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).

EMA’s CHMP recommends approval of Bristol Myers Squibb’s HCC treatment combo

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) in adults.

Scholar Rock submits application of SMA therapy to FDA

Scholar Rock has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for muscle-targeted therapy, apitegromab, aimed at enhancing motor function in individuals with spinal muscular atrophy (SMA) who are already on SMN-targeted therapies.

EMA validates X4’s mavorixafor application for WHIM syndrome treatment

The European Medicines Agency (EMA) has validated X4 Pharmaceuticals’ marketing authorisation application (MAA) submitted for mavorixafor, aimed at treating WHIM syndrome, a rare primary immunodeficiency.

FDA approves Amneal Pharmaceuticals’ Alzheimer’s and oncology treatments

The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.

FDA grants fast track status to Nacuity’s NPI-001 for retinitis pigmentosa

The US Food and Drug Administration (FDA) has granted fast track designation to Nacuity Pharmaceuticals’ NPI-001 (N-acetylcysteine amide) tablets for treating individuals with retinitis pigmentosa (RP).