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Regeneron set for August FDA decision on BCMA bispecific

Regeneron’s bid to join the market for BCMA-targeted bispecific antibodies for multiple myeloma is nearing a conclusion, with the FDA starting a priority review of its lin

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United sues FDA to try to block rival’s drug application

In an unusual move, United Therapeutics has filed a lawsuit against the FDA that claims the regulator is sidestepping established norms in allowing rival Liquidia to file

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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

Regeneron set for August FDA decision on BCMA bispecific

United sues FDA to try to block rival’s drug application

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

Harnessing the cell's own degradation machinery, with Benedi...

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