FDA to Review Inavolisib Combo for HR-Positive, HER2-Negative Breast Cancer
The Food and Drug Administration (FDA) granted a breakthrough therapy designation to the novel drug inavolisib to be used in combination with Ibrance (palbociclib) and fulvestrant to treat patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer that recurred (came back) on or within 12 months of postsurgical endocrine treatment.

Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review
In an FDA briefing document, agency staff said the data showed that long-acting weekly insulin increased the risk of low blood sugar in patients with type 1 diabetes.

NeuraLink's BCI Advances Amidst Challenges: Patient Complications and FDA Approvals
Elon Musk’s Neuralink has emerged at the forefront of brain-computer interface (BCI) technology, promising to enable individuals with paralysis to control computers and other devices through thought alone.

FDA increasing efforts to support CTGT product development
FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products.

While not FDA approved, ketamine offers relief for chronic pain, mental health disorders
Some medical professionals believe that when used as infusion therapy, the tranquilizer is effective in treating mental health conditions such as depression, anxiety and obsessive-compulsive disorder that do not improve with standard treatments.

FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance
While the FDA's recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties.

FDA Withdraws Approval of Truseltiq for Advanced Cholangiocarcinoma
The Food and Drug Administration (FDA) has made the final decision to withdraw the approval of Truseltiq (infigratinib) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Medical device company to plead guilty in faulty lead testing device case
The manufacturer of a device that detects lead in blood has agreed to plead guilty in a case of covering up the device’s malfunction leading to false test results.

Hawaii Court Rules Against Bristol Myers, Sanofi In Blood Clot Drug Case, Increases Liability To $916M
A judge in Hawaii has reportedly ordered Bristol Myers Squibb & Co and Sanofi to pay the state over $916 million for failing to warn non-white patients about health risks associated with their blood thinner Plavix.




This Newsletter is powered by the
Ongage Email Platform
Click here for more information