US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
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.
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‘Major Milestone:’ FDA Gives CLIA Waiver To Chlamydia, Gonorrhea Test
The 30-minute Binx IO test will now be available to more than 220,000 point-of-care facilities that have a CLIA waiver. Health experts say it will help treat patients faster and stymie the spread of STIs.
Everybody Stumbles: US FDA Complete Response Letters To Big Pharma
Explore the 20 CRLs issued to biggest pharma firms since the start of 2021 with Pink Sheet infographic describing US FDA’s concerns and current status.
Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.