ODAC nixes three cancer drug indications, citing dose uncertainty September 30, 2022Vol.48 No.35By Jacquelyn Cobb
Conversation with The Cancer Letter FDA spells out new systematic approach to giving out–and taking away–accelerated approvals in oncology September 23, 2022Vol.48 No.34By Paul Goldberg
Drugs & Targets FDA approves Retevmo for locally advanced or metastatic RET fusion-positive solid tumors, NSCLC September 23, 2022Vol.48 No.34
Drugs & Targets FDA approves Pedmark to reduce the risk of ototoxicity associated with cisplatin for localized pediatric solid tumors September 23, 2022Vol.48 No.34
Drugs & Targets FDA issues safety alert for squamous cell carcinoma and various lymphomas in scar tissue around breast implants September 16, 2022Vol.48 No.33
Drugs & Targets FDA issues revised draft guidance on charging for investigational drugs under an IND application September 09, 2022Vol.48 No.32
Drugs & Targets FDA accepts ImmunityBio’s BLA for bladder cancer therapy N-803 July 29, 2022Vol.48 No.30
Drugs & Targets FDA grants eltanexor with fast track designation; EU Commission designates eltanexor as an orphan medicinal product July 22, 2022Vol.48 No.29
Drugs & Targets FDA accepts BLA for mosunetuzumab in relapsed or refractory follicular lymphoma July 08, 2022Vol.48 No.27
Drugs & TargetsFree FDA approves Breyanzi in relapsed or refractory large B-cell lymphoma after one prior therapy July 01, 2022Vol.48 No.26