Organization
11 Interestana reports mention U.S. Food and Drug Administration, newest first. Each is summarised from the original reporting and links back to its publisher.
The U.S. Food and Drug Administration (FDA) granted accelerated approval on Thursday to rebisufligene etisparvovec, marketed as Fayuvi, marking the first gene therapy authorized for pediatric patients diagnosed with mucopolysaccharidosis type IIIA (MPS IIIA), commonly known as Sanfilippo syndrome type…
A federal judge issued a preliminary injunction on January 20, 2021, halting the Trump administration's plan to limit visa lengths for international graduate students and postdoctoral researchers. This policy, which was set to take effect on January 21, 2021, would…
The medical field's integration of artificial intelligence (AI) is encountering substantial obstacles, leading to a slower adoption rate than anticipated. Despite AI's potential to revolutionize diagnostics, drug discovery, and patient care, practical implementation faces a complex web of challenges.
The U.S. Food and Drug Administration (FDA) has authorized Vitestro's Aletta, marking the first time a robotic system has received clearance to perform routine blood draws. This development arrives at a critical juncture as the United States grapples…
Belgian biotechnology company Argenx experienced a significant stock surge this week after announcing highly positive results from a Phase 3 clinical trial for its experimental drug, empasug. The trial evaluated the efficacy of empasug in treating generalized myasthenia gravis (gMG)…
Pharmaceutical companies Moderna and Merck announced on Wednesday that their experimental mRNA-based cancer vaccine, designed to target a patient's specific tumor mutations, demonstrated efficacy in a Phase 3 clinical trial for melanoma patients.
Moderna and Merck announced promising results from a late-stage clinical trial for a personalized mRNA vaccine designed to prevent the recurrence of melanoma, the deadliest form of skin cancer. The trial, which involved a substantial number of participants, demonstrated…
Johnson & Johnson announced that its new surgical robot, Ottava, has received approval from the U.S. Food and Drug Administration (FDA). This milestone follows years of development and an investment of hundreds of millions of dollars by the healthcare giant.
As of this week, Montana has established a clear pathway for biotech companies to sell experimental drugs directly to consumers. Companies that have completed preliminary testing, which can involve as few as 10 healthy individuals, can now apply…
The U.S.-China biotech relationship is facing increased scrutiny, with concerns about intellectual property theft and state-run companies impacting scientific collaboration. The author, who has covered the biotech and pharma sector for nearly two decades, notes a significant shift in China's…
A cyber extortion group named FulcrumSec claimed to have stolen over a terabyte of data from Novo Nordisk and is reportedly seeking to sell parts of it after an unsuccessful $25 million ransom demand.