Category: Approval

March 29, 2021 Off

FDA approves new indication for Astellas Pharma’s bladder dysfunction drug

By Author

The U.S. Food and Drug Administration approved a new indication for  Astellas Pharma’s  Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.

March 24, 2021 Off

Bayer’s NTRK fusion-positive tumor drug approved in Japan

By Dino Mustafić

Bayer has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for larotrectinib, under the brand name Vitrakvi, for the treatment of Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive advanced or recurrent solid tumors.