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Stealth Bio to Cut Jobs After FDA Rejects Therapy for Rare Disorder
Stealth received the FDA's so-called 'complete response letter' after a 16.5-month review, during which the FDA extended its ...
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 ...
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 ...
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 ...
FDA Approves Topical Foam for Plaque Psoriasis of the Scalp and Body
By Lori Solomon HealthDay ReporterTUESDAY, May 27, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
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 ...
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FDA issues norovirus warning on frozen oysters from South Korea
The U.S. Food and Drug Administration is warning that certain half-shell oysters that are frozen and raw harvested in South ...
FiercePharma4h
Fierce Pharma Asia—Former China FDA head under investigation; Daiichi pulls ADC filing
Daiichi Sankyo, along with partner Merck & Co., has pulled an FDA approval filing for an antibody-drug conjugate (ADC) cancer ...
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 ...
STAT15h
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 ...
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 ...
Healio20h
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 ...