A clinical study showed that the NovoTTF-100L™ System in combination with chemotherapy may help people with malignant pleural mesothelioma extend their lives
Since the year 2000, the U.S. Food and Drug Administration has entered into 40 cooperative arrangements involving foods, pharmaceuticals or medical devices with foreign governments or partners in other nations, according to the FDA.
U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease
AI-based software enables automated enhanced visualization of CT images of the lungs, heart, and aorta
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As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.
Dysport is the first and only FDA-approved botulinum toxin for treatment of both pediatric upper and lower limb spasticity
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology
The opioid crisis has become such a public health crisis that there is now a Prescription Opioid and Heroin Epidemic Awareness Week to focus on the dangers of opioid addiction as well as treatment options treatment – which includes access to Naloxone.
Premarket tobacco product applications (PMTAs) now have new requirements for the content, format and Food and Drug Administration (FDA) review and communication procedures after the FDA issued a proposed rule in their efforts to lessen the number of e-cigarette and other tobacco products on the market.
Endo International plc ("Endo") (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances.
Statement from Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions
First-of-its-kind joint warning letters target 10 websites
Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas, on measuring the progress being made through implementing the FDA Food Safety Modernization Act
Experts Will Present MDX Platform at ISPOR in Denmark in Early November
Luminex Corporation (NASDAQ: LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES® MRSA Assay.
Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman E. ("Ned") Sharpless, M.D., has presented his remarks on the FDA’s planned regulation of electronic nicotine delivery systems (ENDS), including the investigation of vaping illnesses, before the U.S. House Energy and Commerce Subcommittee.
A Performance Dog frozen raw pet food sample has tested positive for Salmonella and Listeria monocytogenes (L. mono), causing the U.S. Food and Drug Administration (FDA) to issue a warning to pet owners.
The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.
Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia (CML)
DURECT Corporation (Nasdaq: DRRX) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).