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 ...
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 ...
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 ...
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.
Managed Healthcare Executive49m
FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or ...
Hosted on MSN39m
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), ...
GlobalData on MSN3d
FDA beats EMA to most approved new drugs in 2024
The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs ...
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 ...
BioSpace5d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
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 ...