Organization
10 Interestana reports mention FDA, newest first. Each is summarised from the original reporting and links back to its publisher.
The U.S. Food and Drug Administration (FDA) has approved ropeginterferon alfa-2b, marketed as Besremi, for the treatment of adults diagnosed with essential thrombocythemia (ET). This approval marks a significant milestone as it is the first new therapeutic agent…
Researchers at MIT, in collaboration with Harvard and the University of Houston, have developed a novel approach to enhance the efficacy of mRNA cancer vaccines by amplifying the body's T-cell response.
The U.S. Food and Drug Administration (FDA) authorized the Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System on Tuesday, marking a significant advancement in diabetes management. This authorization permits the use of the device for individuals aged 2 years…
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Tempus ECG-PH, an artificial intelligence (AI) software designed to interpret electrocardiograms (ECGs) for indicators of pulmonary hypertension (PH).
The U.S. Food and Drug Administration (FDA) authorized the first robotic device capable of independently drawing patients' blood without direct human supervision on Wednesday. This groundbreaking authorization marks a significant advancement in medical automation, potentially streamlining laboratory procedures and improving…
The U.S. Food and Drug Administration (FDA) has granted approval for Moderna's trivalent flu vaccine, designated as mRNA-1010 and marketed under the name mFLUSIVA, for use in individuals aged 50 years and older.
The U.S. Food and Drug Administration (FDA) has granted approval for mFlusiva, a novel influenza vaccine developed by Moderna, marking the first use of mRNA technology in a flu shot for adults aged 50 and older.
The U.S. Food and Drug Administration (FDA) is on the verge of deciding whether to approve the first influenza vaccine that employs messenger RNA (mRNA) technology. This innovative approach mirrors the technology successfully utilized in the COVID-19 vaccines, potentially heralding…
The U.S. Food and Drug Administration (FDA) expanded the approval for exagamglogene autotemcel (exa-cel), marketed as Casgevy, on Wednesday. This gene therapy is now approved for individuals as young as 2 years old who have severe sickle cell disease…
STAT+ reported that pharmaceutical companies are actively engaging in mergers and acquisitions within the biotechnology sector, signaling a resurgence in biotech M&A activity. This trend is underscored by significant deals and a general increase in acquisition interest.