regulatory

News

Insmed's chief medical officer Martina Flammer

FDA starts review of first bronchiectasis drug candidate

The FDA has started a priority review of Insmed's brensocatib, which is pitching to become the first approved therapy for bronchiectasis in the US.

News

CHMP backs Bavarian Nordic's chikungunya jab

Bavarian Nordic is likely just weeks away from bringing the second chikungunya vaccine to the EU, and the first approved for use in adolescents.

News

EMA experts will look again at Leqembi's safety data

It seems Eisai and Biogen have another hurdle to jump over in their bid to get EU approval for their Alzheimer's disease therapy Leqembi.

Market Access

DNA Molecular Genetic Science Biotechnology

Overcoming barriers for global CGT adoption

Cell and gene therapies (CGT) have emerged as the next big thing in medicine, holding the power to deliver cures where none previously existed.

News

Stopwatch starts on reviews of GSK's long-acting asthma drug

Regulators have started reviews of GSK's depemokimab, aiming to become the first drug for asthma that can be dosed twice a year.

Patients

2025 predictions and AI trends for pharma executives

The role of technology – particularly artificial intelligence (AI) – is top of mind for pharma executives this year (if it isn’t already).

FDA starts review of first bronchiectasis drug candidate

CHMP backs Bavarian Nordic's chikungunya jab

EMA experts will look again at Leqembi's safety data

Overcoming barriers for global CGT adoption

Stopwatch starts on reviews of GSK's long-acting asthma drug

2025 predictions and AI trends for pharma executives

Merck and oncology: A conversation with Dr Gregory Lubinieck...

The value of a partner, globally and locally

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