FDA approves milsaperidone for bipolar I disorder and schizophrenia. Explore what this means for psychiatry, competition, and Vanda Pharmaceuticals’ strategy.
FDA expands EVO ICL use to ages 21–60. Discover what this means for refractive surgery, safety data, and the shift away from laser vision correction.
FDA approval expands pitolisant into pediatric cataplexy. Explore what this changes for narcolepsy care, safety, and long-term strategy.
YUVEZZI becomes the first FDA-approved dual-agent eye drop for presbyopia. Find out what this means for Tenpoint Therapeutics and the future of vision care.
Find out how DARZALEX FASPRO’s FDA approval for transplant-ineligible myeloma patients could shift frontline treatment standards.
Sarepta’s gene therapy ELEVIDYS shows 3-year durability in Duchenne muscular dystrophy. Find out what it means for patients, payers, and global rollout.
Organon’s etonogestrel implant NEXPLANON has received FDA approval for extended use up to five years, marking a significant regulatory win for the women’s health–focused pharmaceutical company. The decision, which comes via a supplemental new drug application (sNDA), builds on existing data supporting the implant’s high efficacy and safety profile and broadens its potential utility among
FDA approves NEXPLANON for five years of use with REMS program. Find out how this reshapes contraceptive access, safety, and policy impact.
The recent U.S. Food and Drug Administration (FDA) approval for RevBio Inc. to begin a pilot trial of its regenerative bone adhesive, TETRANITE, in dental ridge augmentation has reignited industry attention around a long-elusive biomaterials category: viable, clinically integrated bone adhesives. While dental applications are the entry point, the real strategic question is whether these
RevBio Inc. has received clearance from the United States Food and Drug Administration to begin a pilot clinical trial of TETRANITE, its regenerative bone adhesive, for dental ridge augmentation. The study will assess the product’s ability to support bone grafting procedures without the use of membranes, meshes, tacks, or screws—offering a potential simplification to a