Regulatory & Compliance

Will Expanded Kisqali Access Transform Early Breast Cancer Care?
Management & Regulatory Will Expanded Kisqali Access Transform Early Breast Cancer Care?

In the dynamic world of biopharma, few individuals possess as vast an understanding of technology and innovation in the field as Ivan Kairatov. With a solid background in research and development, Ivan offers invaluable insights into the recent advancements and decisions impacting the

Can Tevimbra Transform Nasopharyngeal Cancer Treatment?
Management & Regulatory Can Tevimbra Transform Nasopharyngeal Cancer Treatment?

Introducing Ivan Kairatov, a renowned Biopharma expert with an extensive background in technology, innovation, and research and development within the pharma industry. Ivan is here to discuss the recent European Commission approval of Tevimbra for nasopharyngeal cancer, a significant milestone in

FDA Approves Kerendia for Heart Failure with Moderate Ejection Fraction
Management & Regulatory FDA Approves Kerendia for Heart Failure with Moderate Ejection Fraction

In a significant development for cardiac care, Kerendia, a drug crafted by Bayer, has recently gained FDA approval to treat heart failure patients classified with moderate ejection fraction, defined as having a left ventricular ejection fraction (LVEF) of at least 40%. This approval potentially

Review of Alyftrek Cystic Fibrosis Therapy
Management & Regulatory Review of Alyftrek Cystic Fibrosis Therapy

In recent years, innovative developments in medical research have led to significant strides in addressing rare genetic disorders like cystic fibrosis (CF). One remarkable advancement is the introduction of Alyftrek, a triple combination therapy approved by the National Institute for Health and

FDA Boosts Transparency by Revealing CRLs to Aid Drug Approval
Management & Regulatory FDA Boosts Transparency by Revealing CRLs to Aid Drug Approval

With a wealth of experience in biopharma and a keen eye for technological advancement, Ivan Kairatov stands at the forefront of innovation in the industry. Today, he shares his insights on the FDA's recent decision to publish complete response letters (CRLs), a move designed to enhance transparency

Biocon Biologics Gains EC Nod for Denosumab Biosimilars
Management & Regulatory Biocon Biologics Gains EC Nod for Denosumab Biosimilars

Biocon Biologics has achieved a significant milestone with the European Commission's (EC) approval of its denosumab biosimilars, Vevzuo and Evfraxy, marking a pivotal step in the company's expansion within the healthcare sector. This authorization positions Biocon Biologics as a formidable entity

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