EMA backs conditional EU nod for Vijoice in rare life-threatening overgrowth disorder PROS
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
Certification reinforces energy efficiency, sustainability goals, and green manufacturing across SMT’s Surat and Hyderabad facilities
The cleanroom operates under stringent ISO Class 5 conditions, using ultrapure water and air systems
The newly formed SAB will provide strategic direction across research, clinical development, and regulatory pathways
The launch coincides with IBS Awareness Month in April
The online platform is designed to go beyond clinical treatment, offering practical tools, lived-experience insights, and peer-informed support intended to reduce isolation and improve day-to-day coping
The study is a global, randomized, double-blind, placebo-controlled trial testing GLM101 for phosphomannomutase 2 congenital disorder of glycosylation
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