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On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the treatment of wet AMD.

The resubmission is based on positive results of the ...

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 lymphoma (R/R FL).  The FDA’s PDUFA target action date is 30 July 2025.

Regeneron’s odron...

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.

Switzerland is ...

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 under the US Inflation Reduction Act 2022 (IRA).  According to MSD, such price setting wo...

On 25 February 2025, MSD, announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab).  The sBLA is for patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) as neoadjuvant...

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 dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma (...

On 25 February 2025, Formycon and Klinge Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ahzantive®/FYB203 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®.  Ahzantive® is approved in the UK for nAMD and other retina...

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).

Pyzchiva® was developed by Samsung Bi...