Zydus gains FDA Priority Review for saroglitazar as PBC treatment competition intensifies
Zydus’ saroglitazar gets FDA Priority Review in PBC, setting up a key test for dual PPAR therapy in rare liver disease.
Papillary NMIBC could become the next commercial test for ImmunityBio’s ANKTIVA franchise
ANKTIVA already has an NMIBC foothold. The harder test is whether FDA reviewers accept extrapolation into papillary-only disease.
FDA review extension keeps Eisai and Biogen waiting on Leqembi Iqlik starting-dose strategy
Alzheimer’s drugs need easier delivery. Eisai and Biogen now face an FDA timing test that could shape Leqembi’s access story.
No FDA advisory committee for MOLBREEVI: what Savara’s Day 74 Letter means for the August PDUFA review
Savara’s molgramostim BLA faces no FDA adcom. Analysis of what the August 2026 PDUFA date means for autoimmune PAP treatment access. Read more.
Gonorrhea resistance crisis: Can Innoviva’s zoliflodacin rewrite treatment guidelines?
Innoviva Specialty Therapeutics has reported publication of pivotal Phase 3 data in The Lancet showing that its investigational oral antibiotic zoliflodacin was non-inferior to the current standard-of-care dual therapy for uncomplicated urogenital gonorrhea. The study, conducted in partnership with the Global Antibiotic Research & Development Partnership, or GARDP, compared a single oral dose of zoliflodacin […]