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 ...
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 Executive44m
FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or ...
Zacks.com on MSN1h
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), ...
AstraZeneca secures first BTK approval in first-line mantle cell lymphoma
The approval of Calquence marks the first and only BTK inhibitor approved for the first-line treatment of MCL in the US.
Pharmaceutical Technology on MSN11h
FDA approves Amgen’s combo therapy for colorectal cancer
Amgen’s LUMAKRAS and Vectibix combination has received approval from the US FDA for treating KRAS G12C-mutated mCRC.
Innovate gets approval from FDA for MediBeacon TGFR
Innovate (NYSE:VATE) announced today that the U.S. Food and Drug Administration has approved the MediBeacon TGFR for the ...
Daiichi Sankyo Shares Jump After U.S. FDA Approves Breast Cancer Drug
Daiichi Sankyo shares rose sharply after the U.S. Food and Drug Administration approved its breast cancer drug Datroway. Shares were recently 8.7% higher at 4,437 yen, equivalent to $28.39, on Monday ...
IFLScience5h
FDA Authorizes Marketing For Nicotine Pouches For First Time – What Does This Mean?
After reviewing the scientific evidence, the agency has decided 20 ZYN nicotine pouch products can legally be sold in the US.
JD Supra39m
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
ScienceAlert on MSN22h
Parkinson's Discovery Suggests We Could Already Have an FDA-Approved Treatment
Parkinson's symptoms mainly result from the death or impairment of dopamine-producing neurons in the brain's substantia nigra ...
JD Supra22m
FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding ...