The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Fri, 1 May 2026 10:06:51 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161076 Following a reported patient death, FDA places a hold on new patient enrollment at U.S. sites participating in ENIGMA-TRS 2 study, a late-stage trial of a Newron Pharmaceuticals drug for treatment-resistant schizophrenia. Thu, 30 Apr 2026 12:46:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161076 http://fdaweb.com/login.php?sa=v&aid=D5161075 An FDA advisory committee votes 6 to 3 against supporting AstraZeneca’s investigational breast cancer therapy camizestrant. Thu, 30 Apr 2026 12:14:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161075 http://fdaweb.com/login.php?sa=v&aid=D5161074 FDA approves an expanded use for Axsome Therapeutics’s Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to treat agitation associated with dementia due to Alzheimer’s disease. Thu, 30 Apr 2026 12:09:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161074 http://fdaweb.com/login.php?sa=v&aid=D5161073 The U.S. House Appropriations Committee votes to approve a spending bill to fund FDA for fiscal year 2027. Thu, 30 Apr 2026 11:59:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161073 http://fdaweb.com/login.php?sa=v&aid=D5161072 Five Hogan Lovells attorneys discuss ways in which life sciences companies can use artificial intelligence in drug development and regulatory submissions. Thu, 30 Apr 2026 11:07:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161072 http://fdaweb.com/login.php?sa=v&aid=D5161071 The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa omit important risk information and contain elements that make it difficult to comprehend the major statements. Thu, 30 Apr 2026 08:57:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161071 http://fdaweb.com/login.php?sa=v&aid=D5161070 FDA proposes not to include semaglutide, tirzepatide, and liraglutide on the 503 Bulks List of drugs that can be legally compounded from bulk substances. Thu, 30 Apr 2026 08:51:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161070 http://fdaweb.com/login.php?sa=v&aid=D5161069 FDA releases the form FDA-483 with three observations from an inspection at India’s Eugia Pharma Specialties Limited. Thu, 30 Apr 2026 08:49:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161069 http://fdaweb.com/login.php?sa=v&aid=D5161068 FDA warns Franklin, TN-based Lexia LLC about CGMP violations in its production of over-the-counter drugs and cosmetic products Wed, 29 Apr 2026 11:50:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161068 http://fdaweb.com/login.php?sa=v&aid=D5161067 FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in College Station, TX. Wed, 29 Apr 2026 11:37:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161067 http://fdaweb.com/login.php?sa=v&aid=D5161066 Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death. Wed, 29 Apr 2026 10:52:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161066 http://fdaweb.com/login.php?sa=v&aid=D5161065 FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen. Wed, 29 Apr 2026 10:49:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161065 http://fdaweb.com/login.php?sa=v&aid=D5161064 FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile processing, environmental monitoring, and facility maintenance. Wed, 29 Apr 2026 10:45:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161064 http://fdaweb.com/login.php?sa=v&aid=D5161063 FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of AstraZeneca’s breast cancer drug camizestrant. Wed, 29 Apr 2026 10:32:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161063 http://fdaweb.com/login.php?sa=v&aid=D5161062 A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic. Wed, 29 Apr 2026 10:29:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161062 http://fdaweb.com/login.php?sa=v&aid=D5161061 A Clinical Trial Vanguard online post makes the case for further FDA guidance so drug trial sponsors can successfully incorporate artificial intelligence into their work. Wed, 29 Apr 2026 10:18:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161061 http://fdaweb.com/login.php?sa=v&aid=D5161060 Rocket Pharmaceuticals sells an FDA rare pediatric disease priority review voucher for $180 million to support its gene therapy pipeline. Tue, 28 Apr 2026 12:24:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161060 http://fdaweb.com/login.php?sa=v&aid=D5161059 FDA commissioner Marty Makary says the agency is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the agency at the end of the month. Tue, 28 Apr 2026 12:06:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161059 http://fdaweb.com/login.php?sa=v&aid=D5161058 FDA grants a fast track designation to Scancell’s advanced melanoma investigational drug iSCB1+. Tue, 28 Apr 2026 11:33:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161058 http://fdaweb.com/login.php?sa=v&aid=D5161057 FDA releases the form FDA-483 issued after a 2024 inspection at the Excelvision drug manufacturing facility in Annonay, Ardèche, France. Tue, 28 Apr 2026 10:40:00 -0500 http://fdaweb.com/login.php?sa=v&aid=D5161057