Regulation - Approvals

EC grants marketing authorisation for IntraBio’s Aqneursa

The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa (levacetylleucine) to treat neurological symptoms of Niemann-Pick disease type C (NPC).

Biogen’s salanersen gains FDA breakthrough therapy designation for SMA

Biogen has received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for salanersen (BIIB115), an investigational treatment for spinal muscular atrophy (SMA).

AbbVie receives EC approval for Aquipta to treat migraine

AbbVie has received approval from the European Commission (EC) for Aquipta (atogepant), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults, with or without aura.

Roche’s giredestrant secures FDA priority review for breast cancer

The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational oral selective oestrogen receptor degrader (SERD), giredestrant, for breast cancer.

FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).

FDA grants priority review for Sanofi’s venglustat NDA

Sanofi has received a priority review from the US Food and Drug Administration (FDA) for its new drug application (NDA) for venglustat, an oral glucosylceramide synthase inhibitor (GCSi) intended for the treatment of type 3 Gaucher disease (GD3).

Autobahn’s elunetirom receives FDA fast track designation to treat adjunctive bipolar

Autobahn Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for elunetirom, its lead central nervous system (CNS)-directed thyroid hormone receptor agonist.

Pierre Fabre’s Braftovi gains CHMP positive opinion for mCRC

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Pierre Fabre Laboratories’ Braftovi (encorafenib) for the treatment of metastatic colorectal cancer (mCRC) with BRAFV600E mutations.

Japan’s MHLW approves Boehringer’s Jascayd for IPF and PPF

Boehringer Ingelheim has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).