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Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the Outsourcing Facilities Association, a compounding industry group, and FarmaKeio Superior Cu...

BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for adult and paediatric patients (12 years and older) with unresectable or metastati...

On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®.

This follows Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which ...

On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list.  The FDA has confirmed it will take action from 22 April 2025 against state-licensed pharmacies whi...

On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept).  Regeneron had commenced the proceeding in January 2023 in the Seoul Central District Court se...

On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab) as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD)...

On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for the prevention of acute attacks of hereditary angioedema (HAE).

This approval makes...

On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines o...

On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).

Eylea® 8mg was jointly developed b...

On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.

Celltrion’s denosumab biosim...