regulatory

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).

News

Could OTC Cialis for erectile dysfunction reach the US?

Sanofi's consumer healthcare unit Opella could finally be able to bring an OTC PDE-5 inhibitor for erectile dysfunction to the US market.

Market Access

Looking ahead in 2025 and MHRA reliance

International reliance is a mechanism whereby certain medical devices could access the UK market more quickly if they have already been approved by a comparable regulator, rather than under

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

Could OTC Cialis for erectile dysfunction reach the US?

Looking ahead in 2025 and MHRA reliance

Ambrosia's sweet $100m round, and other biofinancings

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

regulatory

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