News

US FDA approves KalVista's oral swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
ALS Community Files Citizens’ Petition asking FDA to Approve NurOwn Stem Cell Therapy
New and Unprecedented Survival, Respiratory, and Biomarker Data Prove that NurOwn Helps People with ALS Live Longer and Live ...
US FDA approves KalVista Pharma's swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
Nationwide Gummies Recall Update as FDA Issues Highest Risk Warning
Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.
BioPharma Dive2m
After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...
The American Journal of Managed Care1h
FDA Approves Sunvozertinib in Non–Small Cell Lung Cancer
The treatment marks the only targeted oral treatment in patients with non–small cell lung cancer with epidermal growth factor ...
FDA approves KalVista’s Ekterly for hereditary angioedema
The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only ...
Watch Milestone Pharmaceuticals For (Likely) Upcoming FDA Approval For Cardamyst
Milestone Pharmaceuticals Inc. is a strong buy under $2 with FDA approval for Cardamyst expected in 2026, offering unique ...
STAT3h
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
The American Journal of Managed Care1h
FDA Approves Sebetralstat for Hereditary Angioedema
For the second time in under 3 weeks, the FDA has approved treatment for the inherited genetic disorder characterized by ...
Targeted Oncology1h
FDA Clears Oncomine Dx Express Test for Sunvozertinib in EGFR Exon 20+ NSCLC
The FDA approves a rapid test for identifying patients with NSCLC eligible for sunvozertinib, enhancing timely, precision ...