Regulatory & Compliance

FDA Fast-Tracks Breyanzi for Relapsed Marginal Zone Lymphoma
Research & Development FDA Fast-Tracks Breyanzi for Relapsed Marginal Zone Lymphoma

What happens when a rare cancer keeps coming back, defying every treatment thrown at it? For adults battling relapsed marginal zone lymphoma (MZL), a subtype of non-Hodgkin lymphoma, this relentless cycle has long been a harsh reality, but a flicker of hope emerges as Bristol Myers Squibb’s

How Does Alhemo Transform Haemophilia Treatment Options?
Management & Regulatory How Does Alhemo Transform Haemophilia Treatment Options?

Hemophilia, a rare inherited bleeding disorder impacting approximately 800,000 individuals globally, has long posed significant challenges for patients and healthcare providers due to the body's impaired ability to form blood clots. For many, the struggle to manage frequent bleeding episodes with

How Will FDA PreCheck Strengthen US Drug Supply Chains?
Management & Regulatory How Will FDA PreCheck Strengthen US Drug Supply Chains?

In a landscape where over 50% of pharmaceuticals distributed in the US are manufactured overseas, the fragility of the drug supply chain has become a pressing concern for national health security, prompting urgent action. Imagine a scenario where a global crisis disrupts access to essential

Keytruda Approved for Advanced Endometrial Cancer by NICE
Management & Regulatory Keytruda Approved for Advanced Endometrial Cancer by NICE

I'm thrilled to sit down with Ivan Kairatov, a renowned biopharma expert with extensive experience in research and development, as well as a deep understanding of technological innovation in the industry. Today, we’re diving into a groundbreaking advancement in cancer treatment: the recent

Roche’s Evrysdi Tablets Approved for SMA Treatment in UK
Management & Regulatory Roche’s Evrysdi Tablets Approved for SMA Treatment in UK

Imagine a world where a rare, life-altering condition like spinal muscular atrophy (SMA), affecting roughly one in 10,000 newborns globally, can be managed with a simple tablet that doesn’t require refrigeration. This scenario is now a reality for many in the UK with the recent approval of Roche’s

AstraZeneca's STRIDE Regimen Revolutionizes Liver Cancer Care
Management & Regulatory AstraZeneca's STRIDE Regimen Revolutionizes Liver Cancer Care

I'm thrilled to sit down with Ivan Kairatov, a renowned biopharma expert with extensive experience in research and development, as well as a deep understanding of technological innovation in the industry. Today, we’re diving into the groundbreaking news about AstraZeneca’s Imfinzi and Imjudo

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