regulatory approval

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Fake Dictionary, Dictionary definition of the word Schizophrenia.

BioXcel gets first approval for agitation drug Igalmi

BioXcel Therapeutics has claimed its first product approval, getting a green light from the FDA for Igalmi as a treatment for agitation in people with schizophrenia or bipolar disorder.

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EMA starts review of Novartis' latecomer PD-1 drug tislelizu...

The EU regulator has started a review of Novartis' PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the dr

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Immunocore gets EU nod for TCR cancer therapy Kimmtrak

Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the Europea

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Gilead beats BMS to FDA okay for early lymphoma CAR-T therap...

Gilead Sciences' Kite Pharma has become the first drugmaker to get FDA approval to use a CAR-T therapy after just one earlier systemic therapy, moving the approach up the treatment pathway.

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Novartis gets first OK for radioligand Pluvicto in prostate ...

Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval for Pluvicto, the first targeted radiolig

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FDA clears Marinus' Ztalmy as first drug for rare epilepsy

People with CDKL5 deficiency disorder (CDD) now have their first FDA-approved treatment, after the US regulator gave the nod to Marinus Pharma's Ztalmy for the rare genetic form of

BioXcel gets first approval for agitation drug Igalmi

EMA starts review of Novartis' latecomer PD-1 drug tislelizu...

Immunocore gets EU nod for TCR cancer therapy Kimmtrak

Gilead beats BMS to FDA okay for early lymphoma CAR-T therap...

Novartis gets first OK for radioligand Pluvicto in prostate ...

FDA clears Marinus' Ztalmy as first drug for rare epilepsy

Court sides with EU on decision to revoke Ocaliva's license

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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