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Downward market trajectory in black bar chart

Outlook blindsided as FDA blocks wet AMD drug once again

Shares in Outlook Therapeutics lost more than half their value after the FDA turned down the company's marketing application for its wet AMD therapy.

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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.

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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.

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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.

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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.

Outlook blindsided as FDA blocks wet AMD drug once again

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

Lilly bags FDA okay for Wegovy pill rival orforglipron

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

regulatory

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