regulatory approval

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Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia

After getting a green light from the European Commission, Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA)

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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/

Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia

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

BMS shakes up R&D under CMO Cristian Massacesi

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regulatory approval

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