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Stealth Bio to cut jobs after FDA rejects therapy for rare disorder
By Sriparna Roy (Reuters) -Privately held Stealth BioTherapeutics said on Thursday the U.S. Food and Drug Administration had ...
US FDA approves Alcon's new dry-eye drug
Spun off from Novartis in 2019, Alcon is betting on new product launches to accelerate sales growth in the second half of ...
STAT14h
A rare disease drug is rejected, even as the FDA talks about new approval pathway
Instead of approving Stealth BioTherapeutics' drug for Barth syndrome, the FDA withheld its endorsement, but decided it may ...
Do you take one of these common allergy medicines? You may experience a rare side effect, FDA warns
“Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical ...
Fierce Biotech16h
'Hanging on by our fingernails': Stealth CEO questions efficiency behind FDA rejection of rare disease drug
Instead, Stealth submitted a new drug application (NDA) seeking approval of elamipretide and the FDA issued its ...
Public Broadcasting Service (PBS)12h
FDA commissioner defends changes to COVID vaccine recommendations
In a significant shift this week, Health Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines will no longer be recommended for healthy children and pregnant individuals. That sparked ...
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WDIO News5h
Alzheimer’s Association weighs in on FDA approval of blood test to help diagnose
The U.S. Food and Drug Administration cleared the first in vitro diagnostic device that tests blood to aid in diagnosing ...
Popular allergy medications linked to severe withdrawal symptoms, FDA warns
FDA warns of severe itching risk when stopping long-term use of allergy medications cetirizine and levocetirizine, affecting ...
FDA chief says pregnant women should decide on Covid vaccine with doctors
Health Secretary Robert F. Kennedy Jr.’s decision to revoke the Covid vaccine recommendation for pregnant women has raised ...
FDA plans to limit COVID shots to those over 65 or with high-risk conditions
Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC ...
FDA changing COVID vaccine guidelines. An NC doctor says who can still get it
The FDA will no longer recommend annual COVID vaccinations for healthy people younger than 65. This means that if you are ...
FDA’s plan to limit covid vaccines worries some who won’t be eligible
If coronavirus vaccines are restricted to seniors and those at high risk, parents of young children and relatives of ...