智通财经APP获悉，阿斯利康 (AZN.US)和第一三共已自愿撤回在欧盟提交的datopotamab deruxtecan（ Dato-DXd ，德曲妥珠单抗）用于治疗局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者的上市许可申请（MAA）。

Preliminary results from TROPION-Lung05 reported at the main ESMO congress last year revealed an overall response rate (ORR) ...

Feedback from the EU indicated that the trial results, which the application was based on, showed that the drug did not ...

The global market for intraocular lymphoma therapy is expected to be worth USD 1.2 billion by the year of 2023. The market, ...

Celltrion secures Korean approval for Aptozumab, first Actemra biosimilar Celltrions Aptozumab approval marks a competitive ...

Gilead Sciences’ seladelpar has been recommended by the European Medicines Agency’s human medicines committee to treat the ...

Eli Lilly's Omvoh wins CHMP backing for treating Crohn's disease, signalling a significant advancement for Crohn's treatment ...

Global Market Expansion Accelerates with Back-to-Back FDA and EC Authorizations Dong-A ST (CEO: Jeong Jae-hoon, KRX: 170900) proudly announces that its Stelara biosimilar, IMULDOSA (Project Name: ...

It was a busy week in the biotech sector with lots of regulatory and pipeline updates. Among bigwigs, Gilead Sciences, Inc.

These observations came after an inspection of the Unit-V API manufacturing facility at Apitoria Pharma, a wholly owned ...

The recent revelation about the approval of self-replicating mRNA vaccines poses significant questions about public safety and governmental transparency. The European Committee for Medicinal Products ...

Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved ...