Regulatory
Track how regulatory decisions alter competitive positioning, launch timelines, and investor expectations across therapeutic areas.
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REGULATORY
The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for neovascular AMD, based on positive clinical trial data.
REGULATORY
The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for nAMD, based on clinical trial data.
REGULATORY
Enhertu has been approved in the EU as the first tumour agnostic HER2-directed therapy for previously treated HER2-positive metastatic solid tumours.
REGULATORY
Datroway has been recommended for approval in the EU as a 1st-line treatment for metastatic triple-negative breast cancer.
REGULATORY
The CHMP has issued a positive opinion for Lilly's Jaypirca (pirtobrutinib) for adults with CLL.
REGULATORY
The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.
REGULATORY
The FDA has accepted Roche's sBLA for Tecentriq in combination with chemotherapy for stage III dMMR/MSI-H colon cancer, with a decision expected by October 9, 2026.
REGULATORY
Enhertu has been recommended for approval by the CHMP for patients with previously treated HER2-positive metastatic solid tumours.
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