February 9, 2024 01:31 PM EST

US and EU regulators begin offering parallel scientific advice to generic drugmakers

Zachary Brennan

Senior Editor

The FDA and European Medicines Agency collaborate often and meet regularly, but the two drug regulators have now announced that for the first time, they …

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US and EU regulators begin offering parallel scientific advice to generic drugmakers

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

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

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

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?

US and EU reg­u­la­tors be­gin of­fer­ing par­al­lel sci­en­tif­ic ad­vice to gener­ic drug­mak­ers

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

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

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

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?

US and EU regulators begin offering parallel scientific advice to generic drugmakers

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

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

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

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?