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On 30 July 2024, Roche announced that the European Commission has approved Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion (RVO).  This follows the positive CHMP opinion for the indication in June 2024.

This is the first approval for a bis...

On 30 July 2024, Johnson & Johnson (J&J) announced that the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed mul...

Five days after Bio-Thera announced the start of its integrated Phase I/III trials for BAT3306 (pembrolizumab), on 30 July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®.  The “Lotus” ...

A United States federal grand jury has indicted a person from India for allegedly selling counterfeit cancer drugs and shipping them to Houston. The counterfeits are reported to include fake versions of MSD’s Keytruda®, Pfizer’s Adcetris® and Bristol Myers Squibb’s Opdivo®....

On 29 July 2024, Roche Canada announced that Health Canada has approved Vabysmo® (faricimab) injection for macular edema secondary to retinal vein occlusion (RVO).   This is the third indication for Vabysmo® in Canada, following approvals for AMD and DME.

Vabysmo® ha...

On 29 July 2024, UK’s NICE (National Institute for Health and Care Excellence) released a statement that it will not recommend the use of trastuzumab deruxtecan (marketed by Daiichi Sankyo/AstraZeneca as Enhertu®) for treatment of HER2-low breast cancer patients after chemo...

On 26 July 2024, Korean Ministry of Food and Drug Safety announced the approval of a prefilled syringe formulation of Amgen’s Xgeva® (denosumab).  International guidelines recommend Xgeva® for patients with bone metastases from various cancers, and its introduction as a pre...

On 26 July 2024, the US FDA issued an alert to healthcare providers in relation to dosing errors associated with compounded injectable semaglutide, including imitations of Novo Nordisk’s Ozempic® and Wegovy®.  The FDA has received reports of adverse events, including hospit...