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FDA approves an at-home flu vaccine
FDA approves FluMist for upcoming flu season
The Food and Drug Administration announced on Friday an approval of a new self- and caregiver-administered nose spray against the flu.
FDA OKs First Flu Vaccine for At-Home Use
The FDA approved FluMist for self- or caregiver-administration, making it the first influenza vaccine that does not need to be administered by a healthcare provider, the agency announced on Friday.
FDA approves first self-administered flu vaccine spray
The Food and Drug Administration announced Friday it had broadened the approval of the FluMist nasal spray to become the first "self-administered" influenza vaccine — though a delay in the change means the vaccine will not be available to ship to homes until next year's flu season at the earliest.
FDA Approves 1st Treatment for Niemann-Pick Disease, Type C
US FDA approves Zevra's treatment for rare genetic disease
The U.S. Food and Drug Administration has approved Zevra Therapeutics' drug for a rare and fatal genetic disorder, making it the first treatment to get a nod for the condition, the health regulator said on Friday.
Zevra Therapeutics’ MIPLYFFA™ (arimoclomol) Receives U.S. FDA Approval as Treatment for Niemann-Pick Disease Type C
MIPLYFFA is the first FDA-approved treatment for Niemann-Pick disease type C (NPC), an ultra-rare and progressive
FDA Approves Zevra's Miplyffa for Niemann-Pick Disease Type C -- 2nd Update
Zevra Therapeutics has won Food and Drug Administration approval of Miplyffa for Niemann-Pick disease type C, or NPC, making it the first drug cleared in the U.S. for the rare neurodegenerative disorder.
FDA, Vanda
US FDA declines to approve Vanda's stomach condition drug
Vanda Pharmaceuticals said on Thursday the U.S. Food and Drug Administration declined to approve its drug to treat a type of stomach condition that disrupts digestion and called for additional studies.
FDA Rejects Vanda Pharma's Application for Gastroparesis Drug Tradipitant
The Food and Drug Administration has turned away a proposed drug from Vanda Pharmaceuticals to treat the stomach disorder gastroparesis. Vanda on Thursday said the FDA has issued a so-called complete response letter for the drug,
VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis
Vanda Pharmaceuticals Inc. VNDA announced that the FDA issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis.
FiercePharma
1h
Sanofi breaks into first-line multiple myeloma with FDA approval for Sarclisa
Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated ...
5h
on MSN
Nationwide Snack Recall Update As FDA Sets Highest Risk Level
The snacks now have a Class I risk level, meaning there is a "reasonable probability" they could cause "serious adverse ...
STAT
5h
FDA’s new head of device safety held senior role at company troubled by safety warnings
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...
The American Journal of Managed Care
6h
FDA Approves Amivantamab for EGFR-Positive NSCLC With Exon 19 Deletion, Exon 21 L858R Substitution
The FDA approval of amivantamab-vmjw (Rybrevant) in combination with chemotherapy is the first targeted treatment to cut ...
1d
FDA finds some 'dairy-free' chocolate products contain milk
Consumers should be aware that some chocolate labeled as "dairy-free" actually contains milk, the U.S. Food and Drug ...
FiercePharma
9h
In addressing inspection shortfall, FDA says it's gaining more inspectors than it's losing
In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA ...
8h
FDA says drug makers will stop producing fentanyl 'lollipops'
Controversial fentanyl lollipops and similar products will no longer be made by drug makers, the U.S. Food and Drug ...
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