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First FDA filing for Novartis' latecomer PD-1 drug tislelizu...

Novartis has filed for FDA approval of tislelizumab – a PD-1 inhibitor licensed from Chinese biotech BeiGene earlier this year – as a sec

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DNA helix in a futuristic concept of the evolution of science and medicine.

FDA slaps clinical hold on BioMarin's PKU gene therapy

BioMarin Pharma has had another setback in its gene therapy development programme, announcing this morning that the FDA has placed a phase 1/2 trial of its candidate for phenylketonuria (PK

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FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer's JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of e

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FDA schedules adcomm for Pfizer's COVID booster filing

The FDA will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech's filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people a

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FDA clears J&J's twice-yearly Invega for schizophrenia

One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson's pharma unit Janssen is trumpeting a new version of its Invega drug that

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FDA grants full approval to Pfizer/BioNTech COVID jab

Pfizer and BioNTech's COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US.

First FDA filing for Novartis' latecomer PD-1 drug tislelizu...

FDA slaps clinical hold on BioMarin's PKU gene therapy

FDA firms up JAK inhibitor warnings after Xeljanz review

FDA schedules adcomm for Pfizer's COVID booster filing

FDA clears J&J's twice-yearly Invega for schizophrenia

FDA grants full approval to Pfizer/BioNTech COVID jab

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

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