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Untitled Letters
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters.
Read MoreStudy casts doubt on gluten as cause of gut ailments among non-coeliacs
Research finds people with self-declared gluten sensitivity experienced symptoms whether or not they ate glutenPeople who report being gluten intolerant but do not have coeliac disease may be experien
Read MoreSTAT+: Your questions answered: How insurers are using AI
In this edition of STAT's AI Prognosis newsletter: A deeper look at how insurers use AI, and implications for patients.
Read MorePeople doing intense exercise experience time warp, study finds
Research suggests those who push themselves when working out perceive time to move more slowlyIf your sessions at the gym seem to drag on for hours, you are in good company.
Read MoreNavigating Controlled Correspondences to Support Generic Drug Development - 02/27/2025
Navigating Controlled Correspondences to Support Generic Drug Development
Read MoreNon-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or
Read MoreAltis says its AI tool can cut risk in cancer trials
Biotech stories you need to read, brought to you by The Readout.
Read MoreVax Skeptic to Lead Autism Study; Liver Damage After RFK Jr. Recs; 'Chemtrail' Bans?
(MedPage Today) -- Note that some links may require registration or subscription. MedPage Today is collecting stories of HHS staffers across all agencies affected by Trump administration cuts.
Read MoreSTAT+: Pharmalittle: We’re reading about drug net prices inching up, uncertain pharma M&A, and more
Investment bankers say large pharma and biotech deals are stalling as executives grapple with mercurial White House economic policies
Read MoreSTAT+: Wave to submit Duchenne drug for approval after Phase 2 success
Wave Life Sciences’ experimental treatment for Duchenne muscular dystrophy hit the mark in a mid-stage study, setting the stage for a new therapeutic option for patients.
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