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 ...
Managed Healthcare Executive50m
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.
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.
Time To Upgrade Merus N.V. To A 'Buy' After The Recent Selloff
Merus is a buy with Bizengri approval for NRG1+ cancers, Petosemtamab's potential, and partnership with BHVN for oncology ...
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 Supra1h
District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought ...
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 ...
GlobalData on MSN11h
FDA approves MediBeacon’s TGFR system for kidney function assessment
The US Food and Drug Administration (FDA) has granted approval to the MediBeacon Transdermal GFR (TGFR) system for evaluating ...
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 ...
JD Supra45m
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 ...