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

Jubilant Biosys doubles early chemistry scale-up capacity with Noida facility

The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants

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

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

Pulmocide halts Phase 3 trial of Opelconazole in severe lung infection

The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit

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

Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC

KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer