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FDA spells out new systematic approach to giving out–and taking away–accelerated approvals in oncology
Conversation with The Cancer Letter

FDA spells out new systematic approach to giving out–and taking away–accelerated approvals in oncology

September 23, 2022
Vol.48 No.34
By Paul Goldberg
Drugs & Targets

FDA approves Retevmo for locally advanced or metastatic RET fusion-positive solid tumors, NSCLC

September 23, 2022
Vol.48 No.34
Drugs & Targets

FDA approves Pedmark to reduce the risk of ototoxicity associated with cisplatin for localized pediatric solid tumors

September 23, 2022
Vol.48 No.34
Drugs & Targets

FDA issues safety alert for squamous cell carcinoma and various lymphomas in scar tissue around breast implants

September 16, 2022
Vol.48 No.33
Drugs & Targets

FDA issues revised draft guidance on charging for investigational drugs under an IND application

September 09, 2022
Vol.48 No.32
Drugs & Targets

FDA accepts ImmunityBio’s BLA for bladder cancer therapy N-803

July 29, 2022
Vol.48 No.30
Drugs & Targets

FDA grants eltanexor with fast track designation; EU Commission designates eltanexor as an orphan medicinal product

July 22, 2022
Vol.48 No.29
Drugs & Targets

FDA accepts BLA for mosunetuzumab in relapsed or refractory follicular lymphoma

July 08, 2022
Vol.48 No.27
Drugs & TargetsFree

FDA approves Breyanzi in relapsed or refractory large B-cell lymphoma after one prior therapy

July 01, 2022
Vol.48 No.26
Drugs & TargetsFree

FDA issues draft guidance on patient-focused drug development

July 01, 2022
Vol.48 No.26

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