2026 FDA Labelling 
The FDA Law Blog
FEBRUARY 21, 2024
Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3
The FDA Law Blog
SEPTEMBER 22, 2024
Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.
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pharmaphorum
JULY 8, 2021
The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Tezepelumab was awarded a breakthrough designation for non-eosinophilic asthma by the FDA in 2018. Results from that programme are due in 2023.
pharmaphorum
OCTOBER 1, 2020
Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused by myelofibrosis. The post CTI wins over FDA to claim early review of myelofibrosis drug appeared first on. Jakafi had sales of more than $1.1
The Checkup by Singlecare
AUGUST 1, 2024
It is an antidepressant approved by the Food and Drug Administration (FDA) to treat major depressive disorder in adults. holds the patent for Trintellix, which is expected to expire in 2026, when a generic version may become available. Trintellix is a brand-name prescription drug containing the active ingredient vortioxetine.
pharmaphorum
AUGUST 27, 2020
Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients who have received at least four prior therapies. billion in 2026.
The Checkup by Singlecare
FEBRUARY 10, 2025
Food and Drug Administration (FDA) approved Januvia in 2006. No generic version of Januvia is available in the United States, but this could change in 2026 when the main patent expires. The first patent, covering the dihydrogen phosphate salt of sitagliptin, expires on November 24, 2026.
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