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CSL closes on EU approval for haemophilia B gene therapy

CSL's gene therapy for haemophilia B has been recommended for approval by the EMA's human medicine committee, setting up a decision by the European Commission early next year.

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NICE backs use of Boehringer's Ofev in IPF from diagnosis

Thousands more UK patients with idiopathic pulmonary fibrosis (IPF) will now be eligible for treatment with Boehringer Ingelheim's Ofev, following new guidance from health technology assess

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FDA adcomm votes down Cytokinetics heart failure drug

An FDA advisory committee has voted against approval of Cytokinetics' cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough.

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Mirati challenges Amgen with FDA okay for KRAS drug

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati's adagrasib as Krazati for a form of lung cancer.

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RSV vaccine race in balance as FDA sets May date for Pfizer ...

The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023.

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Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s

Pfizer and BioNTech have announced that they have submitted an Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) for their Omicron BA.4/BA.5-adapted bivalent CO

CSL closes on EU approval for haemophilia B gene therapy

NICE backs use of Boehringer's Ofev in IPF from diagnosis

FDA adcomm votes down Cytokinetics heart failure drug

Mirati challenges Amgen with FDA okay for KRAS drug

RSV vaccine race in balance as FDA sets May date for Pfizer ...

Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s

FDA relents and will review Moderna's flu shot

How to meet your physicians where they are online

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