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Janssen Pharmaceutical Cos.

Division of Johnson & Johnson
www.janssen.com

Latest From Janssen Pharmaceutical Cos.

Second Chance For Roche’s Polivy At CHMP

It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.

Europe Drug Review

Longer Intervals OK With ViiV's Injectable Anti-HIV Regimen

Topline results from the Phase III ATLAS-2M study indicate that injections every two months of ViiV/Janssen’s two-drug anti-HIV regimen are non-inferior to a once-monthly injectable regimen.

 

Infectious Diseases Clinical Trials

Keeping Track: A Quintet Of Novel Approvals

The latest drug development news and highlights from our US FDA Performance Tracker. 

Approvals Drug Review

Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions

US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.

Approvals Review Pathway
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