June 10, 2022 12:06 PM EDT

Ahead of accelerated approval withdrawal hearing, Covis asks FDA to omit study potentially linking Makena and cancer

Zachary Brennan

Senior Editor

It’s been almost 10 months since the FDA granted Covis Pharma a hearing to review its controversial preterm birth drug Makena, which won an accelerated …

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Ahead of accelerated approval withdrawal hearing, Covis asks FDA to omit study potentially linking Makena and cancer

Zachary Brennan

Senior Editor

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Ahead of ac­cel­er­at­ed ap­proval with­draw­al hear­ing, Co­vis asks FDA to omit study po­ten­tial­ly link­ing Mak­e­na and can­cer

Zachary Brennan

Senior 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

Drug or bi­o­log­ic? An Eli Lil­ly law­suit could im­pact weight loss drug com­pounders

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

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

Ahead of accelerated approval withdrawal hearing, Covis asks FDA to omit study potentially linking Makena and cancer

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

Drug or biologic? An Eli Lilly lawsuit could impact weight loss drug compounders

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

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