New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease
The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
To date, 30 crore vaccines have been produced as part of the commitment made to the Government of India
It signals Cordis' renewed investment in innovation
Pankaj Patel, Chairman, Zydus Lifesciences; Umang Vohra, CEO, Cipla; G V Prasad, Co-Chairman, Dr Reddy's; Nilesh Gupta, MD, Lupin and Dilip Shanghvi, MD, Sun Pharmaceuticals sharing their vision to outline the roadmap for the industry.
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
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