Regulatory & Compliance

EU Panel Backs Darzalex for Early-Stage Multiple Myeloma
Management & Regulatory EU Panel Backs Darzalex for Early-Stage Multiple Myeloma

In the world of oncology, advancements in treatment options often mark pivotal moments in patient care. Ivan Kairatov, a biopharma expert with profound knowledge in tech and innovation, shares insights into the nuanced landscape of smouldering multiple myeloma (SMM) and its treatment. With his

Should Doctors Get Their Own Regulatory Body?
Management & Regulatory Should Doctors Get Their Own Regulatory Body?

Recent developments in the United Kingdom's medical regulatory sphere have stirred significant discourse among healthcare professionals, primarily focusing on the need for an exclusive regulatory framework for doctors. The British Medical Association (BMA) has been vocal about the necessity of

FDA Grants Accelerated Nod for Datroway in Lung Cancer Treatment
Management & Regulatory FDA Grants Accelerated Nod for Datroway in Lung Cancer Treatment

The US FDA's accelerated approval of Datroway (datopotamab deruxtecan) marks a notable advancement in the realm of lung cancer therapy. This approval is groundbreaking, as Datroway is the first TROP2-directed therapy sanctioned for lung cancer in the United States, specifically targeting a

Is Dupixent the Breakthrough for Bullous Pemphigoid Relief?
Management & Regulatory Is Dupixent the Breakthrough for Bullous Pemphigoid Relief?

In recent developments, Dupixent, co-developed by Sanofi and Regeneron, has emerged as a promising solution for individuals suffering from bullous pemphigoid (BP), a debilitating skin disorder predominantly impacting older adults. This drug's approval is seen as a groundbreaking advancement by

Australia Debates Deregulation of GM Foods Amid Transparency Concerns
Biotech & Bioprocessing Australia Debates Deregulation of GM Foods Amid Transparency Concerns

The recent proposal by Food Standards Australia and New Zealand (FSANZ) has sparked a heated debate regarding the potential deregulation of genetically modified (GM) foods, positioning Australia at a critical juncture in food regulation. The proposal, known as Proposal P1055, has drawn significant

NICE Recommends Spevigo for Severe Pustular Psoriasis Treatment
Management & Regulatory NICE Recommends Spevigo for Severe Pustular Psoriasis Treatment

Living with a condition like generalized pustular psoriasis (GPP) brings a unique set of challenges characterized by unpredictable skin flare-ups that can devastate both physical health and emotional well-being. Imagine managing an illness where each day might usher in severe, painful blisters,

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