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US, EU regulators start swift reviews of Servier glioma drug

The US FDA and EMA in the EU have started accelerated reviews of Servier’s vorasidenib for IDH-mutated low-grade glioma, which is vying to become the first targeted therapy for this a

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FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

GSK’s antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval, said the drugmaker th

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3rd ADC Analytical Development Summit

The 3rd ADC Analytical Development Summit is your only industry-dedicated meeting providing you with the key insights to ensure y

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FDA sets date for Adaptimmune’s sarcoma drug verdict

The FDA is due to decide by 4th August whether to approve Adaptimmune’s engineered T-cell therapy for advanced synovial sarcoma, afamitresgene autoleucel (afami-cel), afte

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FDA starts swift review of tumour-agnostic use of Enhertu

AstraZeneca and Daiichi Sankyo’s Enhertu could become the first therapy approved by the FDA for use in any HER2-positive cancer, regardless of its location in the body.

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CHMP turns down Neuraxpharm, Apellis drugs

The EMA’s human medicines committee refused marketing approvals for two drugs from Neuraxpharm and Apellis at its January meeting, but both companies have said they will a

US, EU regulators start swift reviews of Servier glioma drug

FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

3rd ADC Analytical Development Summit

FDA sets date for Adaptimmune’s sarcoma drug verdict

FDA starts swift review of tumour-agnostic use of Enhertu

CHMP turns down Neuraxpharm, Apellis drugs

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