regulatory

News

Bayer files 'safer, greener' MRI contrast agent in US

FDA starts its review of Bayer's gadoquatrane, an MRI contrast agent that reduces the amount of gadolinium in medical imaging procedures.

Market Access

Early strategic evidence planning is a key success factor in...

As the European Union (EU) ushers in a new era of health technology regulation, pharmaceutical companies face both unprecedented challenges and opportunities.

News

PTC stung by FDA decision not to approve rare disease drug

It looks like PTC will have to carry out another trial of its drug for Friedreich ataxia before the FDA will consider approval.

News

Court sides with Vanda over FDA's Hetlioz rejection

A court has ordered the FDA to revisit a decision to turn down a drug for jet lag developed by Vanda, potentially setting a crucial legal precedent.

News

Leaked MAHA draft signposts US health reform under Trump

A leaked version of the Make America Healthy Again programme for the Trump administration has plenty for the pharma industry to stew over.

Digital

Digital marketing worked. Now pharma must reorganise around ...

Remember when I said that patients are coming to doctors with formed opinions – if they come to physicians at all?

Bayer files 'safer, greener' MRI contrast agent in US

Early strategic evidence planning is a key success factor in...

PTC stung by FDA decision not to approve rare disease drug

Court sides with Vanda over FDA's Hetlioz rejection

Leaked MAHA draft signposts US health reform under Trump

Digital marketing worked. Now pharma must reorganise around ...

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

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