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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
Lumoxiti (moxetumomab pasudotox-tdfk) injection has been approved to treat certain instances of relapsed or refractory hairy cell leukemia

FDA Approves Novel Treatment for Hairy Cell Leukemia

Lumoxiti, a CD22-directed cytotoxin, approved for adults who have had at least two prior therapies
Cassipa (buprenorphine and naloxone)

FDA Approves New Treatment for Opioid Dependence

The sublingual buprenorphine and naloxone combo should be part of a complete treatment plan
Oxervate (cenegermin) has been approved by the U.S. Food and Drug Administration to treat neurotrophic keratitis

FDA Approves First Drug for Neurotrophic Keratitis

Oxervate, a topical eye drop, led to complete corneal healing among 70 percent of study participants
Poteligeo (mogamulizumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with two rare types of non-Hodgkin lymphoma.

FDA Approves Poteligeo for Rare Types of Non-Hodgkin Lymphoma

Drug approved to treat relapsed or refractory mycosis fungoides and Sézary syndrome