| FDA Newswatch Today's News |
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| FDA encourages industry to adopt modeling tools to ensure stable processes |
| 25 Oct 2021 20:26:01 UT |
| Posted 25 October 2021 | By Joanne S. Eglovitch An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling... |
| FDA Grants Fast Track Designation to Nemvaleukin Alfa Plus Pembrolizumab for Platinum-Resistant Ovarian Cancer |
| 25 Oct 2021 20:00:52 UT |
| Patients with platinum-resistant ovarian cancer appear to benefit from treatment with nemvaleukin alfa and pembrolizumab, a combination which was granted a fast track designation for this indication... |
| Federal Court Sides with FDA and Upholds GRAS Rule |
| 25 Oct 2021 12:59:27 UT |
| [co-author: Connie Potter] The U.S. District Court for the Southern District of New York granted the U.S. Food and Drug Administration’s (FDA or the Agency) motion for summary judgment on September... |
| FDA approves Bausch + Lomb and Clearside’s XIPERE for macular edema |
| 25 Oct 2021 17:30:00 UT |
| The FDA has approved XIPERE for the treatment of macular edema associated with uveitis The FDA approved XIPERETM (triamcinolone acetonide injectable suspension) for suprachoroidal use. It will be... |
| FDA Clinical Hold Lifted on Clinical Trials Involving Rusfertide |
| 25 Oct 2021 15:30:00 UT |
| The US Food and Drug Administration (FDA) has lifted a clinical hold that had been placed on the injectable hepcidin mimetic agent rusfertide (PTG-300), it was announced on October 11, 2021, in a... |
| Agenus Voluntarily Withdraws BLA for its PD-1 Inhibitor Balstilimab for Cervical Cancer on Heels of FDA Approval of Keytruda for Same Indication |
| 25 Oct 2021 16:00:00 UT |
| Agenus Bio announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor, for recurrent or metastatic cervical cancer with disease progression... |
| FDA Approves Targeted Therapy for Macular Edema |
| 25 Oct 2021 16:15:29 UT |
| The FDA has approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. Developed by... |
| First Interchangeable Biosimilar to Adalimumab Gets FDA Approval |
| 25 Oct 2021 15:25:00 UT |
| The Food and Drug Administration has approved Cyltezo® (adalimumab-adbm) as the first interchangeable biosimilar to Humira® (adalimumab). Cyltezo, a tumor necrosis factor (TNF) blocker, is indicated... |
| Mira's Confirm Wand Receives a Greenlight From the US FDA as an Accurate Tool to Confirm Ovulation |
| 25 Oct 2021 16:00:01 UT |
| Mira's newly released progesterone test wands is now listed as an FDA-registered over-the-counter tool to detect pregnanediol glucuronide for the confirmation of ovulation. PLEASANTON, Calif. -... |
| Roche Announces FDA Approves its Susvimo, Therapeutic Approach for Neovascular or Wet Age-Related Macular Degeneration |
| 22 Oct 2021 18:30:00 UT |
| Roche announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo? (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with... |
| Spatz Medical Announces FDA Approval of Spatz3 Gastric Balloon, the First Adjustable Gastric Balloon |
| 23 Oct 2021 14:32:45 UT |
| Dr. Jeffrey Brooks, Founder of Spatz-FGIA Inc The Spatz3 Gastric Balloon Spatz3 is the fifth balloon to receive FDA approval and its pivotal FDA clinical trial results demonstrated a 15% decrease... |
| How Can FDA Regulation Build Transparency into Health Care AI Tools? |
| 23 Oct 2021 00:23:30 UT |
| In October, the U.S. Food and Drug Administration (FDA) held a workshop on the regulation of artificial intelligence (AI) in health care. While the FDA carefully reviews clinical trial data in a... |
| FDA Lifts Clinical Hold on Rusfertide Trials |
| 23 Oct 2021 00:25:32 UT |
| The U.S. Food and Drug Administration has lifted its full clinical hold on Protagonist Therapeutics’ clinical studies of rusfertide. The clinical hold was announced on September 17 after the company... |
| FDA: Recall issued for 22,000 vials of antibiotic |
| 22 Oct 2021 23:57:39 UT |
| (WKBN) — The Food and Drug Administration announced this week that drug manufacturer Merck is recalling 22,000 vials of IV antibiotic CUBICIN 500mg... |
| FDA Places Hold on Tryp Therapeutics’ Phase IIa Trial for Eating Disorders |
| 22 Oct 2021 23:00:00 UT |
| Tryp Therapeutics announced that the U.S FDA has placed a clinical hold on the Company's Phase 2a study evaluating TRP-8802 for eating disorders. The notification from the FDA did not provide a... |
| FDA Clears Language Independent Computerized Test to Detect Cognitive Impairment |
| 22 Oct 2021 18:00:00 UT |
| The Food and Drug Administration (FDA) has cleared the CognICA Integrated Cognitive Assessment (ICA) test to be marketed as a medical device to detect cognitive impairment. CognICA is a 5-minute,... |
| FDA Approves Another Interchangeable Biosimilar Drug |
| 22 Oct 2021 00:00:00 UT |
| On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained... |
| Lawmakers push FDA to require training for professionals prescribing opioids |
| 22 Oct 2021 20:42:05 UT |
| AUGUSTA COUNTY, Va. (WHSV) - Even though opioid dispensing has decreased in recent years, the Centers for Disease Control and Prevention reported there were still more than 153 million opioid... |
| Eminent Spine’s Anterior Cervical Plate System Receives FDA Clearance for Enhanced Curvature and Low-Profile Locking Tab |
| 22 Oct 2021 16:29:52 UT |
| Eminent Spine’s Anterior Cervical Plate System has received... |
| FDA finds Hennepin Healthcare doctors flouted patient safety laws in sedative studies |
| 21 Oct 2021 22:02:00 UT |
| Hennepin Healthcare doctors failed to comply with federal safety laws in experimental drug research on members of the public comparing ketamine and other powerful sedatives, the FDA informed the... |
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