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).

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.

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.

BALVERSA (erdafitinib) has been granted marketing approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of the most common type of bladder cancer, metastatic or unresectable urothelial carcinoma.

Theramex, a dedicated women’s health company, has announced that the Scottish Medicines Consortium (SMC) has recommended YSELTY (linzagolix) for the treatment of moderate or severe symptoms of uterine fibroids (UFs) in adult women of reproductive age.

Approval of an updated version of the Nuvaxovid COVID-19 vaccine, developed by Novavax, has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA), to target the omicron JN.1 COVID-19 subvariant.

Earlier in November, Johnson & Johnson Innovative Medicine have applied to the US Food and Drug Agency (FDA) and the European Medicines Agency (EMA) for the approval of a new indication for DARZALEX FASPRO (daratumumab and hyluronidase-fihj).

The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Santen’s Roclanda (netarsudil 0.02% and latanoprost 0.005%) as an option for patients suffering from primary open-angle glaucoma (poag) or ocular hypertension.

Last month, the Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medicines Agency (EMA) announced that it has adopted a positive opinion for Novartis’ Kisquali (ribociclib) as an adjuvant in the treatment of adults with hormone receptor-positive/human epidermal growth factor 2negative (hr+/her2-) early breast cancer (ebc).

Wainzua (Eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the EU by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). The drug will be used as a treatment for hereditary transthyretin-mediated amyloidosis in adult patients who have stage 1 or 2 polyneuropathy (commonly referred to as hattr-pn or attrv-pn).

Clinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair.

Headlands Research, a multinational network of clinical research sites, has launched a new clinical trials site in El Paso, Texas, US.