regulatory approval

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Gilead buoyed by Trodelvy OK in new breast cancer use

The reversal of fortunes for Gilead Sciences' Trodelvy in an advanced form of breast cancer is complete, with an FDA approval unlocking what could be a sizeable new market

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Stemline first to market with oral SERD for breast cancer

Menarini subsidiary Stemline Therapeutics has won FDA approval for Orserdu, the first in a new class of oral selective oestrogen receptor degrader (SERD) drugs that provide a new form

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Lilly breaks new ground for BTK class with Jaypirca approval

Eli Lilly has picked up an FDA approval for its non-covalent BTK inhibitor Jaypirca in relapsed mantle cell lymphoma (MCL) patients who relapse after treatment with current drugs in the cla

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Luye claims its first FDA approval, for bi-weekly schizophre...

China's Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks.

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EU clears AstraZeneca's new-form severe asthma drug Tezspire

AstraZeneca's first-in-class severe asthma therapy Tezspire has been approved in the EU in a new pen injector formulation suitable for administration by patients themselves.

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EU clears Roche's flu drug Xofluza in very young children

With this year's influenza season off to an early start and showing signs of being particularly aggressive, the EU has extended the approved uses of Roche's antiviral Xofluza to include tre

Gilead buoyed by Trodelvy OK in new breast cancer use

Stemline first to market with oral SERD for breast cancer

Lilly breaks new ground for BTK class with Jaypirca approval

Luye claims its first FDA approval, for bi-weekly schizophre...

EU clears AstraZeneca's new-form severe asthma drug Tezspire

EU clears Roche's flu drug Xofluza in very young children

Delivering the right behavioural ingredients for the moment,...

How to meet your physicians where they are online

regulatory approval

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