regulatory approval

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Regeneron gets long-awaited FDA okay for myeloma drug

Regeneron's bid to join the crowded US market for BCMA-targeted bispecific antibodies for multiple myeloma has finally been realised.

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After FDA says no, Bayer bags EU nod for twice-yearly Eylea

Bayer has been given a leg up in the competitive market for VEGF therapies used to treat eye diseases with a new EU approval for Eylea 8mg.

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PTC Therapeutics' chief executive Matthew Klein.

Germany will be first launch for PTC's phenylketonuria drug

PTC Therapeutics' treatment for the rare disease PKU, Sephience, will launch in its first market next month after getting EU approval.

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AZ, Daiichi get Datroway nod in lung cancer on second try

AZ and Daiichi Sankyo have claimed FDA approval for Datroway in lung cancer after switching indications for the TROP2-directed drug.

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Dupixent is first FDA-approved drug for rare skin disease

The long list of therapeutic uses for Sanofi and Regeneron's Dupixent has been lengthened by an FDA approval for rare skin disease bullous pemphigoid.

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Gilead's twice-yearly PrEP drug is cleared by FDA

Gilead has FDA approval for a twice-yearly PrEP drug, but could proposed cuts to US funding for HIV prevention programmes hinder its take-up?

Regeneron gets long-awaited FDA okay for myeloma drug

After FDA says no, Bayer bags EU nod for twice-yearly Eylea

Germany will be first launch for PTC's phenylketonuria drug

AZ, Daiichi get Datroway nod in lung cancer on second try

Dupixent is first FDA-approved drug for rare skin disease

Gilead's twice-yearly PrEP drug is cleared by FDA

Are Makary's priority review vouchers about to be canned?

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regulatory approval

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