March 8, 2023 03:00 PM ESTUpdated 04:03 PM

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

Paul Schloesser

Associate Editor

An FDA advisory committee is meeting on Thursday to weigh a potential label expansion for Roche’s potential blockbuster Polivy, but the agency has some concerns …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

Paul Schloesser

Associate Editor

Sign up to read this article for free.

Patient dies in Neurogene's Rett syndrome study

Lilly's board undergoes more changes; Merck strategy chief joins Roger Perlmutter at Eikon

Surrounded by AI bio giants, tiny startup Nabla Bio makes de novo antibodies look more like drugs

Halozyme withdraws Evotec acquisition proposal after biotech is 'unwilling to engage'

From vaccines to psychedelics, five drugmakers on what could change under a Trump administration

Are programs with compounded GLP-1s safe for your population?

FDA rais­es ques­tions in ad­comm brief­ing docs for Roche's Po­livy la­bel ex­pan­sion

Paul Schloesser

Associate Editor

Sign up to read this article for free.

Pa­tient dies in Neu­ro­gene's Rett syn­drome study

Lil­ly's board un­der­goes more changes; Mer­ck strat­e­gy chief joins Roger Perl­mut­ter at Eikon

Sur­round­ed by AI bio gi­ants, tiny start­up Nabla Bio makes de no­vo an­ti­bod­ies look more like drugs

Halozyme with­draws Evotec ac­qui­si­tion pro­pos­al af­ter biotech is 'un­will­ing to en­gage'

From vac­cines to psy­che­delics, five drug­mak­ers on what could change un­der a Trump ad­min­is­tra­tion

Are pro­grams with com­pound­ed GLP-1s safe for your pop­u­la­tion?

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

Patient dies in Neurogene's Rett syndrome study

Lilly's board undergoes more changes; Merck strategy chief joins Roger Perlmutter at Eikon

Surrounded by AI bio giants, tiny startup Nabla Bio makes de novo antibodies look more like drugs

Halozyme withdraws Evotec acquisition proposal after biotech is 'unwilling to engage'

From vaccines to psychedelics, five drugmakers on what could change under a Trump administration

Are programs with compounded GLP-1s safe for your population?