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US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products

 
• By Bridget Silverman

From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.

gonorrhea bacteria. Alamy - 2CBCWKP
• Source: Alamy

The particular exigencies of gonorrhea have the US Food and Drug Administration seeking input on current thinking just five years after the agency issued a final guidance document.

The FDA joined with the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Disease to host a virtual workshop on development of antimicrobial drugs...

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Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.