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Japan clears first CLDN18.2 drug, Astellas’ Vyloy

Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment

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MSD leaps on FDA approval of PAH drug sotatercept

MSD’s sotatercept has become the first FDA-approved therapy for pulmonary arterial hypertension (PAH) that addresses the underlying mechanism behind the disease, rather th

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At second ask, FDA clears AZ’s Ultomiris for NMOSD

AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier applicati

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CHMP backs Novartis’ Fabhalta as first oral therapy for PNH

The March meeting of the EMA’s human medicines committee (CHMP) saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for ra

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Eisai and Biogen facing delay to Leqembi in Europe

Around 14 months after Eisai and Biogen’s Leqembi was filed for approval in the EU, the bloc’s regulatory authority has delayed making a decision on the Alzheimer’s drug.

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FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

Italfarmaco’s oral HDAC inhibitor givinostat has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD), becoming the first non-steroidal option for

Japan clears first CLDN18.2 drug, Astellas’ Vyloy

MSD leaps on FDA approval of PAH drug sotatercept

At second ask, FDA clears AZ’s Ultomiris for NMOSD

CHMP backs Novartis’ Fabhalta as first oral therapy for PNH

Eisai and Biogen facing delay to Leqembi in Europe

FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

Astellas pays $285m for Audax cancer drug, and other deals

Discover a new era of healthcare panel engagement: Grounded ...

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