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Basilea Pharmaceutica, ceftobiprole antibiotic

Basilea completes ceftobiprole marathon with FDA approval

Basilea Pharmaceutica will finally be able to bring its antibiotic ceftobiprole to the US market, around 15 years after the drug was first turned down by the FDA.

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$Eko Health and ejection fraction$

FDA clears AI that detects heart failure using a stethoscope

The FDA has cleared an artificial intelligence algorithm that can detect signs of heart failure in seconds using a digital stethoscope during a standard physical exam.

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FDA clears first DTx for depression from Otsuka, Click

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder.

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FDA clears AZ’s new PNH therapy Voydeya

AstraZeneca’s Voydeya has become the first oral Factor D inhibitor to be approved by the FDA as a treatment for the rare disease paroxysmal nocturnal haemoglobinuria (PNH)

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Akebia joins GSK in US market for oral CKD anaemia drugs

The FDA has approved Akebia Therapeutics’ vadadustat as a treatment for anaemia caused by chronic kidney disease (CKD) in dialysis patients, becoming the first rival to GS

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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

Basilea completes ceftobiprole marathon with FDA approval

FDA clears AI that detects heart failure using a stethoscope

FDA clears first DTx for depression from Otsuka, Click

FDA clears AZ’s new PNH therapy Voydeya

Akebia joins GSK in US market for oral CKD anaemia drugs

Japan clears first CLDN18.2 drug, Astellas’ Vyloy

BMS shakes up R&D under CMO Cristian Massacesi

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