EMA Recommends Susvimo for Neovascular Age-Related Macular Degeneration
EMA recommends Susvimo, an ocular implant that releases ranibizumab over time, as a new treatment option for adults with stable neovascular age-related macular degeneration.
EMAFirst Oral IL-23 Receptor Antagonist Recommended for Plaque Psoriasis
EMA recommends Icotyde (icotrokinra), the first oral medicine targeting the interleukin-23 pathway, for moderate-to-severe plaque psoriasis in adults and adolescents.
EMAFDA Selects Dexcom as First Participant in TEMPO Pilot
FDA named Dexcom as the first manufacturer selected for the TEMPO for Digital Health Devices Pilot, a program pairing digital health technology with the CMS ACCESS Model to improve outcomes for people with chronic diseases.
FDAFDA Revokes Orange B, Proposes Removing Citrus Red No. 2
FDA took two actions targeting petroleum-based color additives, revoking Orange B and proposing to revoke Citrus Red No. 2, as it continues efforts to phase out artificial dyes from the U.S. food supply.
FDAFDA Approves Lipfendra, First Oral PCSK9 Inhibitor for High Cholesterol
FDA approves Lipfendra (enlicitide), the first oral PCSK9 inhibitor, as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia including HeFH.
FDAFDA Proposes Rule to Modernize Drug Manufacturing Registration
FDA proposes streamlined registration for distributed drug manufacturers and clarifies foreign facility requirements under the PREVENT Pandemics Act.
FDAEMA Fast Tracks Review of Daraxonrasib for Metastatic Pancreatic Cancer
EMA's CHMP starts phased review of daraxonrasib, a medicine for metastatic pancreatic cancer, to accelerate assessment for patients with limited treatment options.
EMAMarketing Authorisation for Tavneos (Avacopan) Recommended for Revocation
CHMP recommends revoking Tavneos' EU marketing authorisation after finding that the pivotal Advocate study data are incorrect and misleading due to GCP breaches.
EMAFDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
FDA issues supplemental approval for Casgevy, the first CRISPR/Cas9 gene therapy, for patients 2 years and older with sickle cell disease or transfusion-dependent beta thalassemia.
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