US regulators have granted a fast track designation to Sanofi’s mRNA chlamydia vaccine, putting it in line for development benefits and an expedited review.

San Diego-headquartered biotechnology company GRI Bio has strengthened its global intellectual property portfolio with the addition of two new patents.

The Scottish Medicines Consortium (SMC) has approved Ipsen’s Iqirvo (elafibranor) in NHS Scotland to treat the rare liver disease primary biliary cholangitis (PBC).

Japan’s Ministry of Health, Labour and Welfare has authorised the marketing and manufacturing of Sanofi and Regeneron’s chronic obstructive pulmonary disease (COPD) treatment Dupixent (dupilumab).

Besins Healthcare has launched in the UK its new treatment, based on progesterone, to prevent miscarriage.

UCB’s Fintepla (fenfluramine) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged two years and older.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Telix Pharmaceuticals’ imaging agent Illuccix (gozetotide) for use in adult prostate cancer patients who are undergoing a position emission tomography (PET) scan.

The European Commission (EC) has approved acoramidis to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy (ATTR-CM), according to an announcement from the drug’s developer BridgeBio Pharma.

The US Food and Drug Administration (FDA) has approved Samsung Bioepis’ biosimilars referencing Amgen’s bone disease therapy denosumab.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to ANDEMBRY (garadacimab) by CSL for the prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients over the age of 12.

Johnson & Johnson company Janssen-Cilag Interenational NV has announced news that the European Commission (EC) has approved a marketing authorisation for the combination of LASCLUZE (lazertinib) and RYBREVANT (amivantamab) for first-in-line treatment of adult patients with epidermal growth factor receptor (EGFR) mutations exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations in non-small cell lung cancer (NSCLC).

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to be used as treatment of Duchenne Muscular Dystophy (DMD) in patients who are aged 4 or older in the UK.