regulatory

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EU starts review of Enhertu in HER2-ultra-low breast cancer

The EMA has started a review of AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) that could see the drug being used in advanced breast cancer with even lower levels of the HER

Market Access

Overcoming regulatory hurdles to unleash breakthrough innova...

The life sciences industry is currently undergoing a significant transformation, driven by the rapid development of new modalities such as cell and gene therapies (CAGT), and substantial ne

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FDA shoots down Lykos' MDMA therapy for PTSD

The FDA has denied Lykos Therapeutics' marketing application for its post-traumatic stress disorder (PTSD) therapy based on MDMA, also known as ecstasy, in a setback for the emerging psyche

Digital

AI in the medical devices sector: Fostering innovation while...

Among all the changes happening in the healthcare landscape in the last few years, the advent of digital health technology stands out as one poised to fuel innovation and revolutionise heal

News

Actinium's radioligand filing plans scuppered by FDA

Shares in Actinium Pharmaceuticals have lost almost two-thirds of their value after the FDA asked for a second clinical trial before it would consider reviewing the company's Iomab-B radiol

News

FDA panel backs Zevra's arimoclomol, after earlier rejection

An FDA advisory committee has recommended approval of Zevra Therapeutics' arimoclomol for the ultra-rare disorder Niemann-Pick disease, three years after the regulator rejected the drug.

EU starts review of Enhertu in HER2-ultra-low breast cancer

Overcoming regulatory hurdles to unleash breakthrough innova...

FDA shoots down Lykos' MDMA therapy for PTSD

AI in the medical devices sector: Fostering innovation while...

Actinium's radioligand filing plans scuppered by FDA

FDA panel backs Zevra's arimoclomol, after earlier rejection

Biotech is back, with Craig Ackerman

Using AI-driven synthetic personas to take your insights fur...

regulatory

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