regulatory approval

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Rosacea case showing redness and inflammatory papules and pustules

Journey slips on FDA approval of rosacea therapy

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.

News

Novartis gets FDA okay for frontline use of Scemblix in CML

Novartis has picked up a new FDA approval for its chronic myeloid leukaemia therapy Scemblix that it believes is critical to unlocking the drug's blockbuster sales potential.

News

Pfizer gets a leg up in RSV as FDA clears jab for all adults

A new FDA approval has given Pfizer a broader label for its respiratory syncytial virus (RSV) vaccine Abrysvo than rival shots from GSK and Moderna, but it may not make much of a difference

News

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.

News

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.

News

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.

Journey slips on FDA approval of rosacea therapy

Novartis gets FDA okay for frontline use of Scemblix in CML

Pfizer gets a leg up in RSV as FDA clears jab for all adults

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

Neurogene drops high-dose arm in Rett study after death

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

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