regulatory approval

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FDA changes its mind and approves Takeda’s Eohilia

In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE).

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Roche gets first world okay for PNH drug crovalimab

China has become the first country in the world to approve Roche’s anti-complement C5 antibody crovalimab, the only treatment for the rare disorder paroxysmal nocturnal ha

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GSK’s Omjjara EU-cleared for splenomegaly in myelofibrosis

GSK’s $1.9 billion takeover of Sierra Oncology has delivered the first new product, with the EU approval of Omjjara for the treatment of enlarged spleen (splenomegaly) or

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AZ bags first approval for PNH therapy danicopan, in Japan

AstraZeneca has claimed its first regulatory approval for oral Factor D inhibitor danicopan, getting a green light in Japan for the drug as Voydeya for the treatment of pa

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Keytruda breaks new ground in cervical cancer

MSD’s checkpoint inhibitor Keytruda has been cleared by the FDA for use in newly diagnosed cervical cancer patients with less severe disease, becoming the first anti-PD-1/

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China is third country to approve Alzheimer’s drug Leqembi

Eisai and Biogen have a third regulatory approval for their amyloid-targeting Alzheimer’s disease therapy Leqembi, after it was greenlit by China’s National Medical Produc

FDA changes its mind and approves Takeda’s Eohilia

Roche gets first world okay for PNH drug crovalimab

GSK’s Omjjara EU-cleared for splenomegaly in myelofibrosis

AZ bags first approval for PNH therapy danicopan, in Japan

Keytruda breaks new ground in cervical cancer

China is third country to approve Alzheimer’s drug Leqembi

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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