Browsing Tag
United States Food and Drug Administration
192 posts
Acrux (ASX: ACR) secures clearer FDA Phase III pathway for female testosterone treatment
Acrux has received formal FDA feedback defining the Phase III clinical development requirements for Female Testosterone MDTS, potentially supporting a future United States registration application while leaving trial funding, safety evidence and commercial partnerships unresolved.
Roche’s vamikibart sustains vision gains for 52 weeks as July 2027 FDA decision approaches
Genentech has reported sustained visual improvements and reduced retinal swelling through one year in two Phase III studies of vamikibart for uveitic macular edema. Approximately two-thirds of eligible patients required no retreatment after week 16, strengthening the potential treatment's durability profile. However, mixed statistical results between the pivotal trials and the absence of a direct steroid comparison remain important considerations ahead of the expected July 2027 FDA decision.
EUROAPI targets North American compounding market through MEDISCA as peptide strategy expands
EUROAPI has entered a strategic distribution partnership with MEDISCA to expand European-manufactured pharmaceutical ingredient access in North America and explore peptide opportunities. The agreement offers a potential route to new customers as EUROAPI restructures its manufacturing business, but undisclosed contract economics and tightening US compounding regulations leave its financial impact uncertain.
BridgeBio targets achondroplasia market with first potential oral therapy as FDA fast-tracks infigratinib
BridgeBio’s oral infigratinib wins FDA Priority Review, setting up a February decision and potential challenge to injectable achondroplasia drugs.
Novartis strengthens oral BTK franchise as Rhapsido expands beyond chronic spontaneous urticaria
Novartis expands Rhapsido into symptomatic dermographism as early sales grow and remibrutinib advances across MS and immune diseases.
Cerevance advances non-dopaminergic Parkinson’s strategy after positive solengepras Phase 3 trial
Cerevance’s solengepras wins Phase 3 in Parkinson’s disease, opening an FDA path and a potential first-in-class GPR6 commercial opportunity.
Click Therapeutics faces reimbursement test as Motivista opens new schizophrenia treatment market
Motivista wins FDA clearance for schizophrenia negative symptoms as Click Therapeutics turns to payer coverage, adoption and commercial launch.
BridgeBio’s next rare-disease franchise approaches FDA decision with new BBP-418 cardiac evidence
BridgeBio’s BBP-418 adds encouraging cardiac data ahead of a November FDA decision that could create the first approved LGMD therapy.
icotec gains up to $60,905 Medicare add-on for CMORE CT spine system
icotec’s radiolucent CMORE CT spine system can now qualify for a Medicare new technology add-on payment of up to $60,905 per eligible inpatient case, reducing a major economic barrier as the Swiss medtech company expands its Carbon/PEEK platform in the United States.
Imugene (ASX:IMU) jumps 19% as azer-cel opportunity meets a funding reset
Imugene Limited shares jumped 18.92% to A$0.044 on October 5 as trading activity accelerated from a 52-week low. The rebound puts azer-cel, Imugene's sharply reduced cost base and its recently replenished funding runway back in focus.