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Feb 26, 2025
On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular
Feb 26, 2025
On 26 February 2025, CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and certain paediatric patients.
Feb 25, 2025
On 25 February 2025, MSD, published its 2024 Annual Report, which revealed the company’s expectation that Keytruda® (pembrolizumab) will be selected in 2026 for government price setting
Feb 25, 2025
On 25 February 2025, MSD, announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab)
Feb 25, 2025
On 25 February 2025, Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and
Feb 25, 2025
On 25 February 2025, Formycon and Klinge Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ahzantive®/FYB203 (aflibercept),
Feb 24, 2025
On 24 February 2025, Sandoz announced the US launch of Pyzchiva® (ustekinumab-ttwe), biosimilar to J&J/Janssen’s Stelara®. On the same date, Biocon Biologics announced the US launch of Yesintek™ (ustekinumab-kfce/Bmab 1200).
Feb 24, 2025
On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023
Feb 24, 2025
On 24 February 2025, Celltrion announced that European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab). Avtozma® is approved for all indications of
Feb 24, 2025
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
Feb 24, 2025
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
Feb 21, 2025
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®.
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