May 22, 2023 02:52 PM EDT

FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA

Zachary Brennan

Senior Editor

The FDA is scaling back when it will grant up to two 6-month periods of exclusivity to pharma sponsors once they complete FDA-mandated written requests …

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FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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FDA plans to on­ly is­sue pe­di­atric ex­clu­siv­i­ty for new stud­ies — not just those re­quired un­der PREA

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Eu­ro­pean drug reg­u­la­tor re­jects Alzheimer's drug Leqem­bi, cit­ing safe­ty con­cerns

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FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

European drug regulator rejects Alzheimer's drug Leqembi, citing safety concerns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?