Iterum Therapeutics plc
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Latest From Iterum Therapeutics plc
Keeping Track: Entasis’ Antibiotic Xacduro, Two Opioid Misuse Therapies Clear US FDA; Pfizer’s Paxlovid Makes It Official
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Vaginal Yeast Infections Are A Bright Spot For Anti-Infective Development
Working with US FDA was key to developing clinical trials in the absence of regulatory precedents in recurrent vulvovaginal candidiasis, Scynexis VP tells the Pink Sheet; exposure profiles drove different trial designs for Scynexis’ Brexafemme and Mycovia’s just-launched Vivjoa.
US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters
COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.
Deal Watch: Visus Begins Charting Its Direction In Ophthalmology With Two Deals
Seattle biotech raised $36m series A in March, now obtains glaucoma and AMD drug candidates along with delivery technology. Alligator, Orion partner on bispecific antibodies for cancer.
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