Regulatory & Compliance

Biogen’s Qalsody Wins UK Approval for Rare ALS Treatment
Management & Regulatory Biogen’s Qalsody Wins UK Approval for Rare ALS Treatment

What happens when a disease as merciless as amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), strikes a tiny fraction of patients with a genetic twist that makes it even deadlier? For the roughly 2% of ALS sufferers with mutations in the SOD1 gene, life has often felt

Can Donanemab Transform Early Alzheimer’s Treatment in Europe?
Management & Regulatory Can Donanemab Transform Early Alzheimer’s Treatment in Europe?

What if a single monthly infusion could halt the heartbreaking decline of memory and independence for millions of Europeans with early Alzheimer’s disease, bringing hope to families across the continent? This question, once a distant dream, now edges closer to reality with donanemab, a pioneering

How Does Sarclisa Redefine Multiple Myeloma Treatment?
Management & Regulatory How Does Sarclisa Redefine Multiple Myeloma Treatment?

In the complex world of oncology, multiple myeloma (MM) stands as a formidable challenge, affecting thousands across Europe with its intricate disease mechanisms and diverse patient needs. As the second most common blood cancer after non-Hodgkin lymphoma, MM impacts around 46,000 new individuals

Can GOP AGs Stop Telehealth Abortions and Shield Laws?
Tech & Innovation Can GOP AGs Stop Telehealth Abortions and Shield Laws?

In the complex aftermath of the Supreme Court's 2022 Dobbs v. Jackson Women's Health Organization ruling, which dismantled nationwide abortion rights, a fierce struggle over reproductive healthcare has erupted across state lines in the United States. Republican state attorneys general (AGs) are

EMA Endorses Moderna's Updated Vaccine for 2025-2026 Season
Management & Regulatory EMA Endorses Moderna's Updated Vaccine for 2025-2026 Season

The European Medicines Agency (EMA) has recommended the approval of Moderna's LP.8.1-adapted COVID-19 vaccine to address the challenges posed by the SARS-CoV-2 variant LP.8.1. Following the guidance of EMA's Emergency Task Force, the formulation of Spikevax has been tailored to combat the current

FDA Grants Priority Review to Imfinzi for Early Gastric Cancer
Management & Regulatory FDA Grants Priority Review to Imfinzi for Early Gastric Cancer

In the ever-evolving landscape of cancer treatment, AstraZeneca’s Imfinzi represents a significant step forward in managing early-stage gastric cancer. Ivan Kairatov, a biopharmaceutical expert with a wealth of knowledge in biotechnology and innovation, shares insights into how this immunotherapy

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