Results 31 to 40 of about 1,046,073 (109)

Reshaping study design for faster extrapolation-based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN-NASPGHAN position paper. [PDF]

J Pediatr Gastroenterol Nutr
Turner D, Assa A, Malham M, Bar-Asher SY, Rayan C, Hyams JS, Uhlig HH, Pasternak B, Wilson DC, Michel HK, de Ridder L, Zuckerman E, Aloi M, Szitanyi P, Dubinsky MC, Griffiths AM, Saldana R, Martín-de-Carpi J, Wine E, Russell RK, Adler J, Picoraro J.   +21 more
europepmc   +1 more source

Twelve years of European cancer drug approval-a systematic investigation of the 'magnitude of clinical benefit'. [PDF]

ESMO Open, 2021
Grössmann N, Wolf S, Rothschedl E, Wild C.   +3 more
europepmc   +1 more source

The Importance of Cost-Effectiveness in New Drug Approval: Stroke Burden and Tenecteplase Efficacy. [PDF]

J Clin Neurol
Kwon HS, Kim BJ.
europepmc   +1 more source

Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness. [PDF]

Front Med (Lausanne), 2021
McPhail M, Weiss E, Bubela T.
europepmc   +1 more source

Drug development for leukemia: comprehensive analysis of clinical trials from first report to drug approval. [PDF]

Blood Adv
Tjioe KC, Miranda-Galvis M, Mamouni K, Freitas T, Sharara M, Santellano B, Guillén-Lopez C, Cortes JE.   +7 more
europepmc   +1 more source

Novel drug approval by the FDA: Ekterly (Sebetralstat), oral plasma kallikrein inhibitor for treating acute attacks of hereditary angioedema. [PDF]

Ann Med Surg (Lond)
Gulalai, Miraj SA, Mahato RK.
europepmc   +1 more source

Advances on anticancer new drugs in China and the USA in 2020: from ongoing trial to drug approval. [PDF]

J Natl Cancer Cent, 2021
Huang H, Miao H, Wang J, Wu D, Lei Q, Wang S, Fang H, Tang Y, Li N, Xu B, He J.   +10 more
europepmc   +1 more source

Using Dose-Escalation and -Expansion Cohort Study as Pivotal Trial for Targeted Anticancer Drug Approval. [PDF]

JCO Precis Oncol
Huang Y, Zhu T, Zhong J, Yuan J.
europepmc   +1 more source

Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years. [PDF]

Clin Pharmacol Ther
Mita S, Ono S.
europepmc   +1 more source

Children With Inflammatory Bowel Diseases are Disadvantaged by Current Drug Approval Policies: A Call for Urgent Change. [PDF]

Crohns Colitis 360
Sahn B, Maltz RM, Rosh JR.
europepmc   +1 more source