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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 or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer.

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 (end-stage kidney disease), and death due to cardiovascular disease in adults with type ...

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) in November 2024 for early Alzheimer’s disease following safety information that ha...

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  The sBLA fo...

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of chronic...

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.

This makes the UK...

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older with C1 esterase inhibitor deficiency or ...

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey, relating to Celltrion’s biosimilar denosumab.
Amgen had commenced proceedings against Celltrion in May 20...

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany.
Steqeyma® was launched in France on 20 January 2025, Italy and Spain in ...

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 treatment of small cell lung cancer (SCLC).

According to Zai Lab, the regulatory...