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News articles from Pharmafile - therapy areas in focus

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CHMP grants positive opinion for J&J’s Rybrevant for lung cancer treatment

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

21 May 2024News
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MHRA approves Ascendis Pharma’s Yorvipath for hypoparathyroidism treatment

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.

21 May 2024News
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FDA approves Roche’s Alecensa as lung cancer treatment

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).

21 May 2024News
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FDA approves Pfizer’s Beqvez for haemophilia B treatment

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

21 May 2024News
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Eko Health’s AI for heart failure detection approved by FDA

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

21 May 2024News
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Regeneron and Mammoth Biosciences to collaborate on CRISPR gene therapies

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.

21 May 2024News
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FDA to review GSK’s meningococcal vaccine candidate

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.

21 May 2024News
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ANGLE and AstraZeneca sign commercial agreement

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.

21 May 2024News
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21 May 2024News
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Pfizer’s RSV vaccine recommended by CDC

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.

1 October 2023News
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Eli Lilly & Boehringer Ingelheim’s Jardiance approved by FDA for treatment of chronic kidney disease

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).

1 October 2023News
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FDA approves GSK’s Ojjaara for the treatment of patients with myelofibrosis and anaemia

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.

1 October 2023News