Medscape12h
FDA Approves Sotorasib + Panitumumab for mCRC
In the CodeBreaK 300 trial, sotorasib and panitumumab had better response rates and improved PFS vs standard-of-care ...
US FDA approves AstraZeneca's drug for breast cancer
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of ...
Medscape2d
FDA Approves New ADC for HR+, HER2- Breast Cancer
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
For first time, FDA approves marketing of nicotine pouch products
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an ...
US FDA approves Amgen's colorectal cancer therapy
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients ...
Managed Healthcare Executive37m
FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or ...
FDA’s START and CoGenT pilot programmes: Streamlining rare disease drug approvals
These initiatives represent a way to accelerate access to treatments that have historically faced longer regulatory pathways.
Zyn nicotine pouches get FDA approval
FDA authorizes Zyn nicotine pouches, citing public health benefits for adult smokers, despite concerns over flavored products ...
FiercePharma4d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
Healio3d
FDA approves therapies for colorectal cancer, mantle cell lymphoma
The FDA approved two oncology regimens on Jan. 16.One is for a subset of patients with colorectal cancer and the other for ...
Healio3d
FDA approves sale of Zyn nicotine pouches following extensive review
The FDA announced it has authorized the marketing of 20 Zyn nicotine pouch products, citing their greater health benefits vs.
The American Journal of Managed Care3d
FDA Grants 2 Traditional Approvals for Acalabrutinib
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...