Janssen, a J&J company, has announced that the CHMP of the EMA has recommended Rybrevant (amivantamab) in combination with chemotherapy.

Ascendis Pharma has announced that the MHRA has granted marketing authorisation for yorvipath (palopegteriparatide; developed as transcon pth) in GB as a parathyroid hormone (pth) replacement therapy for the treatment of adult patients with chronic hypoparathyroidism.

Roche has announced that the FDA has approved Alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Pfizer has announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate-to-severe haemophilia b.

Eko Health has announced that the FDA has approved its low ejection fraction (low EF) detection artificial intelligence (AI).

Regeneron Pharmaceuticals and Mammoth Biosciences have announced a collaboration for the research, development and commercialisation of in vivo CRISPR-based gene-editing therapies for multiple tissue and cell types.

GSK has announced that the FDA has accepted for review a biologics license application (BLA) for its 5-in-1 meningococcal abcwy (menabcwy) vaccine candidate.

ANGLE has announced that it has signed a supplier agreement with AstraZeneca for the development and validation of a methodology that will leverage angle’s existing DNA damage response (DDR) assay for the detection of micronuclei in circulating tumour cells (CTCs) as a measure of DDR.

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Pfizer has announced that the CDC Advisory Committee on Immunization Practices (ACIP) has recommended the company’s bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, for maternal immunisation.

Eli Lilly and Boehringer Ingelheim have announced that the FDA has approved Jardiance (empagliflozin) 10mg tablets to reduce risk of sustained decline in estimated glomerular filtration rate (EGFR), end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease (CKD).

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.