2024 Chemotherapy Labelling 
pharmaphorum
JANUARY 23, 2023
The drug achieved an impressive 84% overall survival rate over 18 months in patients with advanced GEA who received it as a first-line therapy in combination with chemotherapy, according to data from the open-label study. The median progression-free survival (PFS) of 12.5 months, with a median duration of response was 20.4
pharmaphorum
MARCH 8, 2022
In the study, Trodelvy (sacituzumab govitecan) met its objective of reducing progression-free survival in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment – including endocrine drugs, CDK4/6 inhibitors and two to four lines of chemotherapy.
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pharmaphorum
DECEMBER 5, 2022
The positive news comes after a challenging time for GSK, marked by the withdrawal of its US marketing approval for multiple myeloma therapy Blenrep (belantamab mafodotin) last month, along with the narrowing of the label for PARP inhibitor Zejula (niraparib), as well as a retreat from the cell therapy category.
The FDA Law Blog
JANUARY 18, 2024
Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. chemotherapy-induced), pain, and post-traumatic stress disorder. chemotherapy-induced), and pain. chemotherapy-induced), and pain.
The FDA Law Blog
MAY 21, 2024
On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). chemotherapy-induced), and pain.
The FDA Law Blog
MAY 5, 2024
FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products. Three Republican senators on the Foreign Relations Committee advised to consider U.S.
Hospital Pharmacy Europe
MARCH 17, 2025
A total of 1,074 patients underwent randomisation in a 2:2:1 ratio to receive amivantamablazertinib (open-label), osimertinib (blinded), or lazertinib (blinded, to assess the contribution of treatment components). The primary endpoint was progression-free survival in the amivantamablazertinib group as compared with the osimertinib group.
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