The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation
This inspection was conducted following the warning letter issued by the USFDA
The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
Abdomen-pelvis CT is the nation’s highest-volume CT category
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions
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