regulatory

News

GSK bags breakthrough status for B7-H3 ADC for lung cancer

An antibody-drug conjugate (ADC) that GSK licensed from China's Hansoh Pharma in a $1.7 billion deal last year has been given breakthrough status by the FDA.

News

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

News

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

GSK bags breakthrough status for B7-H3 ADC for lung cancer

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

Neurogene drops high-dose arm in Rett study after death

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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