Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment

CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Evotec subsidiary bags Gates Foundation grant to expand global access to biologics

The grant will fund ten new J.MD projects over the next three years, targeting multiple global health threats

Alembic announces USFDA tentative approval for Bosutinib tablets

EpiBiologics secures $107 million in Series B to advance tissue-selective cancer therapies

The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue

Novartis to open Florida radioligand facility

New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US

Alveus Therapeutics launches with $159.8m Series A to advance next-gen obesity drugs

ALV-100 is a bifunctional fusion protein combining glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonism with glucagon-like peptide-1 receptor agonism

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories

Ollin Biosciences’ bispecific antibody outperforms Faricimab in head-to-head Phase 1b trial

DME is among the most challenging retinal diseases to treat and has long served as a proving ground for therapies that ultimately become first-line standard of care in retinal diseases