Complete Response Letter

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

1 month ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

Xspray’s Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues

2 months ago talkbio0Tagged Acute lymphocytic leukemia, Complete Response Letter, contract manufacturer, Dasynoc, Drug Approval Process, manufacturing issues, manufacturing practice, Myeloid Leukemia, Chronic, United States Food and Drug Administration, Xspray Pharma

Dasynoc; Xspray Pharma; FDA; Complete Response Letter; manufacturing issues; good manufacturing practice; contract manufacturer; chronic myeloid leukemia; acute lymphoblastic leukemia; drug approval process

Genentech’s $700M North Carolina Plant and Telix’s FDA CRL Update

3 months ago talkbio0Tagged biomanufacturing, Complete Response Letter, CRL, genentech, Holly Springs, Manufacturing Facilities, Medicinal product acting as imaging agent (product), metabolic medicines, North Carolina, Obesity, Roche (company), Telix, United States Food and Drug Administration

Genentech; Roche; North Carolina; manufacturing facility; $700 million; Holly Springs; metabolic medicines; obesity treatments; biomanufacturing; Telix; FDA; Complete Response Letter (CRL); imaging agent

FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies

3 months ago talkbio0Tagged Clinical Research, Complete Response Letter, drug efficacy, factor IX, Friedreich 's ataxia, Rejection, United States Food and Drug Administration, vatiquinone

FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies