ANNEXON BIOSCIENCES: Announces FDA Fast Track Designation for Novel C1q Inhibitor ANX005 for the Treatment of Guillain-Barré Syndrome
Annexon plans to advance the clinical development of ANX005 for the treatment of GBS
Latest News
INSULET CORPORATION: Insulet’s Omnipod DASH™ System Now FDA Cleared as an Alternate Controller Enabled (ACE) Infusion Pump
Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for an Alternate Controller Enabled Infusion Pump (ACE Pump).
.jpg){kind=tracking}
Myths influencing FDA and CDC vaping policies, ACSH says
The U.S. Food and Drug Administration (FDA) and the U.S. Center for Disease Control (CDC) are relying on myths to scare people away from vaping, according to Alex Berezow of the American Council on Science and Health (ACSH).
EMMAUS LIFE SCIENCES: Reinforces Positive Outcomes of Endari ® Clinical Trials, Including Efficacy Findings That Led to FDA Approval
Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease (SCD) treatment, today released the following summary review of the clinical trials and efficacy findings for Endari®.
FDA draft guidance elicits mixed reactions
Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from stakeholders.
SANDOZ INC.: Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product
Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.
EXACT SCIENCES: Cologuard® Gains FDA Approval For Use In Younger Americans, Ages 45 To 49
Stool DNA test offers a sensitive, noninvasive, at-home option to screen for colorectal cancer, second deadliest cancer in U.S.
WEST CANCER CENTER: The first center in the country to offer the first FDA-approved Mesothelioma treatment in more than 15 years
A clinical study showed that the NovoTTF-100L™ System in combination with chemotherapy may help people with malignant pleural mesothelioma extend their lives
FDA Update: international cooperative arrangements
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.
CARDIOVASCULAR SYSTEMS, INC.: Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip
U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease
SIEMENS HEALTHINEERS: FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers
AI-based software enables automated enhanced visualization of CT images of the lungs, heart, and aorta
Vaping illnesses caused by illegal substances, AVA says
As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.
IPSEN: Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Children, Excluding Cerebral Palsy
Dysport is the first and only FDA-approved botulinum toxin for treatment of both pediatric upper and lower limb spasticity
CERTARA: FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology
FDA working to increase availability of Naloxone
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.
FDA proposes new rule for premarket tobacco product applications
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: Announces Successful Culmination of Litigation Regarding FDA Compounding Policy
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.
U.S. FDA: Statement on continued efforts to evaluate materials in medical devices to address potential safety questions
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