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Futura gets FDA nod for OTC erectile dysfunction therapy

Futura Medical has become the first company in the US to bring a topical erectile dysfunction therapy to market that does not require a prescription.

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FDA panel gives unanimous support to Leqembi

The first full regulatory approval for an amyloid-targeting therapy for Alzheimer’s disease could come within a month, after an expert panel voted 6 to 0 in favour of Eisa

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FDA sets Dec deadline for Vertex, CRISPR sickle cell therapy

The FDA has started a priority review of Vertex Pharma and CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel) in sickle cell disease (SCD), with a decision on approva

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FDA advisors back Beyfortus for RSV prevention

An FDA advisory committee has voted in favour of approving AstraZeneca and Sanofi’s one-shot antibody treatment to prevent respiratory syncytial virus (RSV) disease in inf

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Eisai files Leqembi in Korea, as US prospects firm up

Eisai has filed for approval of its Alzheimer’s disease therapy Leqembi in South Korea, just ahead of an FDA advisory committee meeting that has raised confidence that the

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J&J files Carvykti for earlier use in multiple myeloma

As the ASCO congress drew to a close, Johnson & Johnson filed for FDA approval of its BCMA-targeting CAR-T therapy Carvykti for use earlier in the treatment pathway fo

Futura gets FDA nod for OTC erectile dysfunction therapy

FDA panel gives unanimous support to Leqembi

FDA sets Dec deadline for Vertex, CRISPR sickle cell therapy

FDA advisors back Beyfortus for RSV prevention

Eisai files Leqembi in Korea, as US prospects firm up

J&J files Carvykti for earlier use in multiple myeloma

UK seeks views on indefinite CE marks for medical devices

How to meet your physicians where they are online

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