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US FDA approves KalVista Pharma's swelling disorder drug
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary ...
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 ...
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
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 ...
FDA Issues Most-Serious Risk Warning for Cucumber Recall
Consumption of impacted products could cause "serious adverse health consequences or death," according to the FDA.
PMLive27m
Regeneron’s Lynozyfic granted FDA accelerated approval to treat multiple myeloma
Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug ...
MassDevice40m
Boston Scientific wins expanded FDA nod for Farapulse PFA
Boston Scientific (NYSE: BSX) announced that the FDA approved an expansion to the label of its Farapulse pulsed field ...
Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System
Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the ...
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 ...
Top FDA vaccine official rejected broad use of Covid-19 shots, documents show
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...
Chocolate Recall Update as FDA Sets Risk Warning
Meijer Inc. announced a recall of thousands of cases of Frederik's Dark Chocolate Almonds on June 13 due to the possible ...
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...