regulatory approval

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FDA clears Astellas' Vyloy as first claudin 18.2 cancer drug

At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for certain gastric cancers.

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AbbVie gets continuous Parkinson's drug over the line in US

AbbVie has finally claimed FDA approval for its advanced Parkinson's disease therapy Vyalev, 18 months after the US regulator turned it down with a request for more data.

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Pfizer rounds out haemophilia portfolio with FDA approval

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year.

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Roche gets FDA green light for breast cancer drug Itovebi

The FDA has given Roche its first regulatory approval for PI3K inhibitor Itovebi, clearing the drug as part of a triple therapy for certain types of locally advanced or metastatic breast ca

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BMS ends decades-long drought in novel schizophrenia drugs

Bristol-Myers Squibb's $14 billion bet on buying Karuna Therapeutics looks set to pay off after it got FDA approval for the schizophrenia drug at the heart of the deal.

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AZ gets sought-after lung cancer approval for Tagrisso

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targete

FDA clears Astellas' Vyloy as first claudin 18.2 cancer drug

AbbVie gets continuous Parkinson's drug over the line in US

Pfizer rounds out haemophilia portfolio with FDA approval

Roche gets FDA green light for breast cancer drug Itovebi

BMS ends decades-long drought in novel schizophrenia drugs

AZ gets sought-after lung cancer approval for Tagrisso

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory approval

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