[10]https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma [11]https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ponatinib-chemotherapy-newly-diagnosed-philadelphia-ch...
[11]https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome [12]https://www.fda.gov/drugs/resources-information-approved-drugs/fda-a...
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3 Contains Nonbinding Recommendations annual report to the NDA or ANDA if, after obtaining and analyzing the data in accordance with the protocol, the criteria set forth in the approved stability protocol are met. 11 Such extended dating typically is applied prospectively to newly manufactured lots...
2023年4月3日,FDA加速批准恩诺单抗(Padcev,安斯泰来)联合帕博利珠单抗(Keytruda,默沙东)用于不适合进行含顺铂化疗的局部晚期或转移性尿路上皮癌患者。 12 Omidubicel-onlv(Omisirge) 2023年4月17日,FDA批准Omidubicel-onlv(Omisirge,Gamida Cell Ltd.)用于儿童(12岁及以上)和成年的血液系统恶性肿瘤患者,该类...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-...
不良反应:眼部疾病、疲劳、恶心、头痛和食欲不振等。 REF: 1.https://www.targetedonc.com/fda-briefs/march-2024 2.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma...
1.https://www.targetedonc.com/fda-briefs/march-2024 2.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma 如果您或您的亲人在人生的道路上,
August 8, 2024 By Sean Whooley Purdue Pharma announced that the FDA approved its new drug application (NDA) for the Zurnai (nalmefene injection) auto-injector. The single-dose auto-injector delivers 1.5 mg of nalmefene hydrochloride per actuation. It marks the approved first nalmefene hydroch...
16、S.,known as“novel”drugs.We also made other important approval decisions,such as expanding the use or patient population of previously approved drugs.The 2023 actions,both novel and other important drug approvals,focus on prevention,diag-nosis,and treatment of diseases and conditions such as...