FDA Newswatch Today's News
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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