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The U.S. Food and Drug Administration on Monday approved Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) in pediatric (as young as newborn) and adult patients who have refractory

FDA Approves Drug to Treat Rare Immune Disease

Gamifant first drug to be approved specifically for primary hemophagocytic lymphohistiocytosis
A new version of an over-the-counter asthma inhaler that was taken off the market in 2011 has been approved by the U.S. Food and Drug Administration.

FDA Approves New Version of OTC Primatene Mist

Primatene Mist approved to provide temporary relief for symptoms of mild, intermittent asthma
Ruling against the recommendation of one of its chief experts

FDA Approves Powerful New Opioid Despite Criticisms

Dsuvia use restricted to operating rooms or on the battlefield
For the first time in nearly two decades

FDA Approves First New Influenza Drug in 20 Years

Antiviral drug reduces symptoms of uncomplicated influenza when taken within 48 hours of onset
The U.S. Food and Drug Administration has approved the ID CORE XT DNA-based test to help doctors verify blood compatibility before a transfusion.

FDA Approves New DNA-Based Test to Verify Blood Compatibility

Assay can be used to determine blood donor and patient non-ABO red blood cell types
The first hearing aid that does not require the assistance of an audiologist or other health care provider has been approved by the U.S. Food and Drug Administration.

FDA Approves Marketing of First User-Fitted Hearing Aid

Bose Hearing Aid is user-fitted device for people 18 and older with mild-to-moderate hearing loss
U.S. Food and Drug Administration approval of the Gardasil 9 human papillomavirus vaccine has been expanded to include people ages 27 through 45

FDA Approves HPV Vaccine for People Through Age 45

Updated vaccine designed to prevent cancers and disease caused by nine HPV types
Libtayo (cemiplimab-rwlc) injection has been approved by the U.S. Food and Drug Administration to treat metastatic cutaneous squamous cell carcinoma

FDA Approves New Treatment for Squamous Cell Carcinoma

Libtayo is the sixth FDA-approved immune checkpoint inhibitor targeting the PD-1 pathway
Arikayce (amikacin liposome inhalation suspension) has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex bacteria among patients who do not respond to conventional therapies

FDA Approves New Drug for Antibiotic-Resistant Lung Disease

Arikayce approved to treat lung disease caused by Mycobacterium avium complex bacteria
The PK Papyrus Covered Coronary Stent System has been approved by the U.S. Food and Drug Administration to treat acute coronary artery perforations.

FDA Approves Device for Acute Coronary Artery Perforations

The PK Papyrus device is a balloon-expandable covered coronary stent and delivery system