Psychology Today1h
The Best Way to Treat Alcohol Use Disorder (AUD)
The newest treatment for AUD, acamprosate (Campral) was developed in France. The FDA approved the drug for abstinence ...
Pharm Exec2h
FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer
Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously ...
JD Supra2h
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 ...
Managed Healthcare Executive3h
FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or ...
JD Supra3h
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 ...
Pharm Exec3h
FDA Approves Amgen’s Lumakras Plus Vectibix for KRAS G12C-Mutated Metastatic Colorectal Cancer
Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and ...
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.
TCTMD6h
Misleading Statements Common in Online Ads for Compounded GLP-1s
More than one-third of websites selling their own versions implied the products were the same as the FDA-approved drugs.
IFLScience8h
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.
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.
SiliconRepublic11h
CergenX making Waves with new FDA designation
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
Daily13h
AstraZeneca-Daiichi Sankyo Datroway gets USFDA nod for previously treated Metastatic HR Positive, HER2 Negative Breast Cancer
Tokyo: Daichi Sankyo has announced that DATROWAY (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the ...