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Elixir’s DynamX bioadaptor obtains FDA breakthrough designation
Medical Device Network via Yahoo Finance· 5 days agoThe...diseased vessel to a more natural condition through three different phases. Initially, the...
FDA Issues Final Rule Overhauling Regulation of Medical Gases
The National Law Review· 3 days agoOn June 18, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that governs...
FDA approves MSD’s KEYTRUDA for advanced endometrial cancer
Pharmaceutical Technology via Yahoo Finance· 6 days agoThe...MSD signed a definitive agreement to acquire all outstanding shares of Eyebiotech (EyeBio)...
Supreme Court Abortion Pill Ruling Doesn't Challenge FDA's Authority | JD Supra
JD Supra· 6 days agoThe U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to ...
...Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s...
JD Supra· 6 days agoAvoiding a substantive decision on the merits of the plaintiffs’ case, the Court held that the plaintiffs’ legal and moral objections to elective abortion and the FDA’s increasingly ...
FDA Updates Guidance on Intentional Genomic Alterations in Animals
The National Law Review· 3 days agoIntentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic...
What Does FDA's Draft Platform Guidance Mean For CGT Companies?
BioresearchOnline· 7 days agoThe U.S. FDA released the much-anticipated draft guidance Platform Technology Designation Program...
FDA Warns Yet Another Birth Tissue Company
MedPage Today· 3 days agoThe FDA has warned birth tissue company Neobiosis that its products derived from human amniotic fluid and umbilical cord are unapproved drugs. In its...
FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
The Woonsocket Call· 3 days agoToday, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ...
ISCT States Concerns with Utah Bill Undermining U.S. FDA Power to Protect Patients
Benzinga· 6 days agoThis bill, which took effect on May 1, 2024 (Utah SB0199), attempts to undermine U.S. FDA authority to regulate placental stem cell therapies and poses significant risks for ...
