Tag: FDA
‘Major Milestone’ as Israeli Heart Valve Implanted in First US Patients
Trisol Medical Ltd., an Israeli medical device company, marked a milestone with the successful implantation of its Transcatheter Tricuspid Valve in two patients in the United States.
FDA Approves First RSV Vaccine for Older Adults
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,”
Pfizer’s RSV Vaccine Wins FDA Priority Review
If approved, RSVpreF will become the first RSV vaccine for older adults.
FDA Recommends Vaccinating Children, Israel to Follow
CDC vaccine official Dr. Amanda Cohn said the coronavirus is “the eighth-highest killer of kids in this age group over the past year.”
With 224 New Patients, Israel Renews Coronavirus Emergency Guidelines as US Deaths Near 120,000
A model cited by the White House predicts 200,000 US deaths from coronavirus by October 1.
Israeli Research Finds Gaucher’s Disease Meds Effective Against Coronavirus
The effectiveness of these drugs in patients with generalized viral diseases and COVID-19, in particular, can be relatively quickly examined and made more readily available.
FDA Green-Lights Israeli-US Drug for COVID-19 Treatment Trial
The drug (Aviptadil) to be tried already has a 20-year history of safe use in human beings.
Mnuchin Proposes FDA Branch in Israel, Meets with Health Ministry
The FDA has few branches outside the United States, including those in China, and several European and Latin American nations.
Biogen Prepares to Resubmit Request for FDA Approval of Alzheimer’s Drug
The drug is reported to reduce levels of the plaques, but only slows progression of the disease; it does not cure Alzheimer’s.
FDA Issues Alert over Johnson’s Baby Powder
“On October 18, 2019, Johnson & Johnson voluntarily recalled this product, and consumers who have this lot of baby powder should stop using it.”
Promising Gene Therapy for Visually-Impaired Sheep Now Safe for Human Trials
In Jerusalem day blindness affects 1 in every 5,000 people.
FDA Approves Marketing for Israeli-Developed OCD Treatment
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches.”
FDA Approves Teva Leukemia Treatment
The medication is approved for treatment of recently-diagnosed low-risk adults with acute promyelocytic leukemia (APL).
Teva Pharmaceuticals to Fire 7,000 – Stock Price Plummets
"We are focused on executing meaningful cost reductions, rationalizing our assets and maximizing their value."
BGU Re-Engineers Cancer Drug to Treat ALS
If Dr. Lichtenstein’s research pans out, patients with Alzheimer’s and Parkinson’s might also benefit.
No Victory for V15 and Not Healthy ‘Healthy’ Snack Bars
First thwarted at the Israeli polls, now V15 funder's "healthy" bars are also losers.
Israeli ALS treatment Gets ‘Fast-Track’ FDA Designation
Stem cell treatment developed by Israeli company BrainStorm Cell Therapeutics has been designated by the U.S. Food and Drug Administration (FDA) as a "fast-track" treatment of amyotrophic lateral sclerosis (ALS).
New Cancer Drug Uses Immunotherapy to Treat Metastatic Melanoma
A new cancer treatment to fight metastatic melanoma, Keytruda, has been approved by the FDA.
Teva Wins FDA Approval for Leukemia Drug
The U.S. Food and Drug Administration (FDA) has granted Israeli-based Teva Pharmaceuticals full approval for Synribo, a drug that is injected for adults with...
Israeli Biotech Firm’s Diabetes Drug Passes FDA Phase 2 Trial
The U.S. Food and Drug Administration (FDA) has reported positive results in its Phase 2a trial of an oral insulin capsule produced by Israeli-based...
Israeli Anti-Nausea Pill for Cancer Patients Passes Clinical Trial
Israel’s RedHill Biopharma announced success last week in a major clinical trial of a new drug to prevent nausea in cancer patients.
Immune System Holds ‘Key’ To Promising Haredi Biomedical Start-Up
A small band of haredi biomedical pioneers, ensconced in the Lev Institute of the Jerusalem College of Technology, is on the verge of perfecting revolutionary peptide-based medicine that could cure a variety of life-threatening cancers and debilitating autoimmune diseases such as Crohn's disease.