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Otsuka Pharmaceutical Co. Ltd.

www.otsuka.co.jp/en/

Latest From Otsuka Pharmaceutical Co. Ltd.

Janssen’s Multiple Myeloma Drug Among 11 Products To Get EMA Thumbs Up

The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances. 

Approvals Drug Review

High-Stake Meetings With EMA In Store For Sponsors Of EU Filings

The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

Europe Approvals

Next-Generation BTK Inhibitor Among New Filings At EMA

The European Medicines Agency has begun reviewing a new batch of EU marketing authorization applications.

Drug Review Europe

Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half

With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.

US FDA Performance Tracker Approvals
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