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On 22 August 2024, Pfizer Canada announced that Padcev® (enfortumab vedotin) in combination with MSD’s Keytruda® (pembrolizumab) has been approved by Health Canada for treatment of unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior systemic...

On 22 August 2024, Shanghai Henlius Biotech announced that its partner, Intas subsidiary Accord Healthcare, has received marketing approval from Health Canada for HLX02, the Henlius-developed biosimilar to Roche’s Herceptin® (trastuzumab) to treat early/metastatic breast ca...

On 22 August 2024, AbbVie announced that the UK’s National Institute for Health and Care Excellence (NICE) issued final Technology Appraisal Guidance recommending Skyrizi® (risankizumab) as a treatment option for adults with moderately to severely active ulcerative colitis ...

On 22 August 2024, Eisai and Biogen announced that Leqembi® (lecanemab) has received marketing authorisation from the UK’s MHRA for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease.  The UK is the first country in Europe to autho...

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular car...

On 20 August 2024, the FTC and US Biosimilars Council lent their support to the FDA’s position that data from a switching study or studies may no longer be necessary to support licensure of interchangeable biosimilar medicines.

In draft guidance published by the FDA ...

On 19 August 2024, AbbVie announced that the European Commission (EC) has granted conditional marketing authorisation for its Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines...

On 19 August, Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated a Type II Variation Application for the use of Enhertu® (trastuzumab deruxtecan) as a form of monotherapy treatment for individuals with unresectable or metastatic HER2 low or HER2...