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BioWorld - Tuesday, December 9, 2025
Home » Topics » Regulatory

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FDA approves Fycompa for partial-onset seizures in pediatric patients

Oct. 1, 2018

Sanwa Kagaku Kenkyusho obtains approval for Metoana in Japan

Oct. 1, 2018

FDA approves Vizimpro for first-line treatment of metastatic NSCLC with EGFR mutations

Sep. 28, 2018

FDA approves Emgality for preventive treatment of migraine in adults

Sep. 28, 2018

European Commission approves pegfilgrastim biosimilar Udenyca

Sep. 26, 2018

FDA grants approval for Copiktra for CLL/SLL, accelerated approval in follicular lymphoma

Sep. 25, 2018

Xospata approved in Japan for FLT3 mutation-positive relapsed or refractory AML

Sep. 25, 2018

Beova granted marketing approval in Japan for overactive bladder

Sep. 25, 2018

Eybelis granted marketing approval for glaucoma and ocular hypertension in Japan

Sep. 25, 2018

Lorlatinib receives first approval in Japan

Sep. 21, 2018
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