January 24, 2024 11:55 AM EST

CMC concerns lead to FDA rejection of Theratechnologies’ concentrated version of lipodystrophy drug for HIV patients

Anna Brown

News Reporter

Theratechnologies was handed a complete response letter by the FDA for the more concentrated version of its marketed lipodystrophy drug for HIV patients, Egrifta SV …

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CMC concerns lead to FDA rejection of Theratechnologies’ concentrated version of lipodystrophy drug for HIV patients

Anna Brown

News Reporter

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CMC con­cerns lead to FDA re­jec­tion of Ther­at­e­ch­nolo­gies’ con­cen­trat­ed ver­sion of lipody­s­tro­phy drug for HIV pa­tients

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

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

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CMC concerns lead to FDA rejection of Theratechnologies’ concentrated version of lipodystrophy drug for HIV patients

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?