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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 ...
Tomato recall update as FDA issues highest warning level
The Centers for Disease Control and Prevention has estimated that salmonella causes about 420 deaths annually in the U.S.
US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy
The U.S. Food and Drug Administration has asked for a resubmission of Stealth BioTherapeutics' marketing application for its ...
STAT6h
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 ...
Healio2h
FDA approves Tryptyr to treat dry eye signs, symptoms
The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon. Tryptyr ...
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 ...
MPR53m
FDA Approves Ustekinumab Biosimilar Starjemza
The Food and Drug Administration (FDA) has approved Starjemza ® (ustekinumab-hmny), a biosimilar to Stelara ® (ustekinumab), for the treatment of various chronic inflammatory diseases. Starjemza, ...
Fierce Pharma3h
AACE Pharma slammed with FDA warning letter for contract manufacturer's shortfalls
New Jersey-based AACE Pharmaceuticals has been slammed in an FDA warning letter citing significant violations by its contract ...
FDA Warns of Rare, Surprising Side Effect of Popular Allergy Medications
Two antihistamines, including Zyrtec, are under warning by the FDA after people reported “severe itching” after ceasing ...
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’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 ...