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BioWorld - Friday, December 26, 2025
Home » Topics » Regulatory

Regulatory
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FDA grants accelerated approval to Arikayce for MAC lung disease

Oct. 1, 2018

FDA approves Libtayo for cutaneous squamous cell carcinoma

Oct. 1, 2018

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
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