On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine
On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from
On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable
On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure
On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab)
On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV...
On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their...
On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.
On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry®...
On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to...
On 22 January 2025, Zai Lab announced that the US FDA has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate, for the
On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024...
On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human...
On 22 January 2025, PMLive reported that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Imfinzi® (durvalumab) in combination with chemotherapy
On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B.
On the same day, Genmab announced that worldwide annual net sales of Darzalex® (daratumumab) for 2024, as reported by J&J, totalled USD11.7 billion.