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On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received accelerated approval from the FDA for the treatment of adults with unresectable advanced cutaneous melanoma who experienced dise...

On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V. (a retail pharmacy based in the Netherlands) from selling a compounded semaglutide nasal spray under the name Semanova.  To ...

On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor r...

On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.

Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024.  Biocon and Regeneron settled US BPCIA li...

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab).  The product will be commercialised in the US by Fresenius Kabi.

The FDA approval follows a Complete Response Letter (CRL) issued to Dr ...

On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of England and Wales (Patents Court) by each of Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis (Biosimilar Claimants)...

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016 (vedolizumab), biosimilar to Takeda’s Entyvio®, have been accepted for review by the FDA and Europe...

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous injection formulations.  The companies have signed a strategic memorandum of understanding, including a material transfer a...

On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™ (insulin aspart-fsan) injection, biosimilar to Novo Nordisk’s NovoLog®.  Garzulys™ is indicated to improve glycaemic control in adult and paediatric patients with d...