regulatory approval

News

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

News

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

News

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/

News

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

News

AZ, Sanofi’s Beyfortus cleared in China for RSV prevention

AstraZeneca and Sanofi’s long-acting antibody Beyfortus has been approved in China for the prevention of respiratory syncytial virus (RSV) infections in newborns and infan

News

FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

AstraZeneca and Ionis are planning a US launch next month for Wainua, their treatment for polyneuropathy in life-threatening disease transthyretin-mediated amyloidosis (AT

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

AZ, Sanofi’s Beyfortus cleared in China for RSV prevention

FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

Relief for AZ as Truqap hits the spot in prostate cancer

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

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