FDA Newswatch Today's News
Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facility in Devens, Massachusetts
08 Jun 2023 20:16:12 UT
- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and...
FDA Lifts Partial Clinical Hold on Phase 1 Trial of MT-0169 in Multiple Myeloma, Hodgkin Lymphoma
08 Jun 2023 19:40:12 UT
MT-0169 in Multiple Myeloma, Hodgkin Lymphoma | Image Credit: ©immimagery - stock.adobe.com The FDA has removed a partial clinical hold that had been placed on a phase 1 trial (NCT04017130)...
FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV
08 Jun 2023 19:51:54 UT
Narisara Nami   Moment     A panel of independent advisors to the Food and Drug Administration unanimously recommended Thursday that the antibody nirsevimab be approved for use to protect infants...
FDA Accepts Application for KEYTRUDA® Plus Chemo as Treatment for Advanced or Unresectable Biliary Tract Cancer
08 Jun 2023 19:36:32 UT
iLet Bionic Pancreas Cleared by FDA
08 Jun 2023 19:24:42 UT
The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by the FDA and is now available commercially. The device is offered by Beta Bionics , a medtech company based in...
Water-Free Dry Eye Disease Therapy Vevye Gets FDA Approval
08 Jun 2023 17:58:00 UT
The Food and Drug Administration (FDA) has approved Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. Vevye contains cyclosporine, a...
FDA Approval Broadens Patient Population for Long-Acting Growth Hormone Sogroya
08 Jun 2023 14:00:01 UT
Jun 08 Jun 08, 2023 The FDA recently approved an expanded patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed...
FDA clears smart toilet that measures heart health
08 Jun 2023 18:06:22 UT
The global home health care market is worth approximately $305.7 billion. It is the first time that the health authorities authorize the marketing of an intelligent toilet. Thanks to sensors...
FDA Readies Proposal for Increased Oversight on Lab-developed Tests
08 Jun 2023 18:00:42 UT
The FDA is preparing to increase regulation of a widely used class of tests conducted by laboratories to detect cancer, measure cholesterol, and identify other health issues. The FDA is developing a...
FDA Approval Sought for Pembrolizumab Plus Chemotherapy in Biliary Tract Cancer
08 Jun 2023 16:35:04 UT
The FDA has accepted for review a supplemental...
FDA to Decide on Dostarlimab Plus Chemo Approval in dMMR/MSI-H Advanced Endometrial Cancer in 4 Months
07 Jun 2023 18:06:00 UT
The FDA has accepted the supplemental new drug application (sNDA) for dostarlimab (Jemperli) in combination with chemotherapy for the treatment of patients with mismatch repair deficient...
FDA Approval Sought for Cilta-Cel in Relapsed/Refractory Multiple Myeloma in Adults
07 Jun 2023 18:17:00 UT
Ciltacabtagene autoleucel was recently said to be a new standard-of-care for relapsed or refractory multiple myeloma. Soon, it may be an FDA-approved therapy. A biologics license application (BLA)...
Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi
07 Jun 2023 17:20:45 UT
A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with...
Avinger’s Pantheris LV Image-Guided Atherectomy System Receives FDA 510(k) Clearance
07 Jun 2023 16:21:34 UT
June 7, 2023—Avinger, Inc. announced it has received 510(k) clearance from the FDA for Pantheris LV, its next-generation image-guided atherectomy system for the treatment of peripheral artery disease...
Masimo's (MASI) New FDA Approval to Boost Patient Monitoring
07 Jun 2023 16:36:00 UT
Masimo Corporation MASI received the FDA’s 510(k) clearance for its patient-worn, continuous multi-parameter vital signs monitor, Radius VSM. The monitor, designed on a modular platform, enables...
Alzheimer’s drug market to reach $13 billion due to FDA approval and increased insurance coverage
07 Jun 2023 17:11:45 UT
Lekenbi, developed by drugmakers Eisai and Biogen, received good news on June 1 when the Center for , [+] Medicare and Medicaid Services, which runs Medicare health insurance for the nation’s...
FDA Warns Consumers Not to Use Certain Versions of Ozempic and Wegovy
07 Jun 2023 09:41:08 UT
By: Jack Phillips The U.S. Food and Drug Administration (FDA) warned consumers not to use off-brand versions of weight-loss drugs Ozempic, Rybelsus, and Wegovy because they may not have the same...
FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance
07 Jun 2023 15:18:06 UT
Dive Brief: The U.S. Food and Drug Administration has published its warning letter to iRhythm Technologies, revealing inspectors accused the company of failing to seek clearance before making major...
FDA Approves Novel Treatment for Menopausal Hot Flashes
07 Jun 2023 14:59:42 UT
The FDA has approved fezolinetant as the first neurokinin 3 receptor antagonist approved for the treatment of moderate to severe vasomotor symptoms caused by menopause.  Vasomotor symptoms, often...
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
06 Jun 2023 20:33:23 UT
Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized...

rssfeedwidget.com