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Medicines: Reclassify Your Product

March 4, 2026
Pharmaceutical companies are now encouraged to apply for the reclassification of their products, transitioning them from pharmacy (P), prescription-only (POM), or general sale list (GSL) categories. This initiative, announced by regulatory authorities, aims to streamline access to essential medications and enhance patient care. The context surrounding this move is rooted in the ongoing evolution of…

UniQure Falls Further on Makary Comments

March 4, 2026
Remarks made by FDA Commissioner Robert Califf during a recent CNBC appearance have intensified investor concerns regarding the approval prospects of UniQure’s gene therapy for Huntington’s disease. The comments suggested potential regulatory hurdles that may delay or obstruct the therapy’s path to market, which has led to a notable decline in UniQure’s stock value. This…

Moderna’s combination flu, COVID shot wins over European drug regulators

March 3, 2026
In a significant development, the European Medicines Agency (EMA) has issued a positive recommendation for Moderna’s combination flu and COVID-19 vaccine, marking a notable divergence from the U.S. Food and Drug Administration (FDA), which has maintained stricter approval standards for the same product. This decision underscores the EMA’s confidence in the vaccine’s efficacy and safety…

Generate: Biomedicines Raises $400M IPO, CEO Discusses AI’s Role in Drug Design

March 3, 2026
Generate: Biomedicines has successfully completed a $400 million initial public offering (IPO), marking one of the largest in the biotechnology sector in recent years. The shares are set to begin trading on Friday, signaling a strong market interest in AI-driven biopharmaceutical innovations. This significant capital influx comes at a pivotal moment for the biotech industry,…

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