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FDA Rejects Keytruda Dosing, Fast Tracks Tecentriq Lung Cancer Review

Contrasts With EMA Decision

 
• By Andrew McConaghie

Keytruda is set to remain dominant despite knockback, though Tecentriq could claim prized NSCLC adjuvant approval first

Merck

Merck & Co. Inc. has had its submission for a more convenient six-week dosing of its blockbuster immunotherapy treatment Keytruda refused by the US Food and Drug Administration.

The regulator has issued a complete response letter (CRL) to the company, which is seeking to introduce the every-six-weeks administration...

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Executives On The Move: Three New CEOs And CFOs Among This Week’s Changes

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Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 
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Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 
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