February 23, 2024 10:24 AM EST

FDA rejects Melinta, Venatorx’s UTI antibiotic over CMC issues

Anna Brown

News Reporter

The FDA handed a CRL to Melinta Therapeutics and Venatorx Pharmaceuticals for their urinary tract infection antibiotic, with the agency calling for more information on …

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FDA rejects Melinta, Venatorx’s UTI antibiotic over CMC issues

Anna Brown

News Reporter

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FDA re­jects Melin­ta, Ve­na­torx’s UTI an­tibi­ot­ic over CMC is­sues

Anna Brown

News Reporter

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?

FDA rejects Melinta, Venatorx’s UTI antibiotic over CMC issues

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?