A comprehensive view of New Drug/Biologic License Application (NDA/BLA). This page highlights a small sample of our full coverage.
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Recent Articles

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Swiss biotech ObsEva cancels linzagolix oral uterine fibroids candidate after FDA halts approval application, returns license to Japanese firm Kissei; company to start mass dismissal of employees, with number of jobs to be cut to be determined later

Novartis buys Mallinckrodt’s FDA priority review voucher for US$100M to speed up future FDA drug applications; voucher shortens FDA’s drug review process from 10 months to six months

Shionogi files for approval in Japan for S-217622, a therapeutic drug for COVID-19; treatment is an orally administered antiviral

GSK and Sanofi plan to apply for regulatory authorizations of COVID-19 vaccine; trials show 100% efficacy against severe COVID-19 disease and hospitalization, 57.9% efficacy against any symptomatic disease

Ocugen announces the FDA has lifted clinical hold on submission of its new COVID-19 vaccine candidate COVAXIN; vaccine is a whole-virion inactivated COVID-19, rather than mRNA technology

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