Application procedure
Despite Government Shutdown, Companies Still Plan to Submit FDA Applications
FDA shutdown; new drug applications; biologic applications; user fees; pharmaceutical delays; government funding lapse; AbbVie; Amgen; Bristol Myers Squibb; J&J; Pfizer
FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time
FDA; complete response letters; real-time disclosure; drug applications; radical transparency; pending applications; regulatory transparency; public health; openFDA
Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay
Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases
FDA Misses IND Deadline for Coya’s ALS Asset, Citing Resource Constraints
FDA; Coya Therapeutics; IND application; ALS; clinical trial delay; COYA 302; resource shortage
Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss
Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal
Astellas Withdraws European Application for Geographic Atrophy Treatment Izervay
Astellas, Izervay, geographic atrophy, European application withdrawal, avacincaptad pegol
Capricor Secures $35M Deal for European Rights to DMD Therapy Ahead of FDA Application
Capricor Therapeutics, Duchenne muscular dystrophy (DMD), cell therapy, FDA application, European rights, $35M deal
Gilead Sciences Receives $210 Million Venture Capital Funding to Expand Trodelvy’s Application in Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Carcinoma, Capital, Trodelvy, Trodelvy’s, Application procedure