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.

Questioning almost 9,000 participants across 12 countries in Latin America and Europe, the research revealed significant knowledge gaps surrounding human papillomavirus (HPV) and highlighted several significant barriers preventing women from screening for it.

French start-up Bioptimus has announced that its H-optimus-o biology reference artificial intelligence (AI) foundation model has been wholly integrated into Proscia’s Concentriq Embeddings software platform, with the aim of enabling quicker and more efficient breakthroughs in AI development for therapeutic research.

Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV)-1 vaccine candidate (SAV0001) at bench scale.

Clinical-stage biotech company Aravax has announced that it has completed phase 2 recruitment for its precision therapy (pvx108) study, which investigates treatment of peanut allergies.