Tag: FDA approval
New GSK Drug Approval Poses Competition for Dupixent
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First Blood Test FDA Approved for Alzheimer’s Diagnosis
The Food and Drug Administration gave the green light on Friday for the first blood test to diagnose Alzheimer’s disease, providing a faster way for patients to identify the neurological condition and start treatment....
FDA Approval: Ionis Rare Disease Therapy Lowers Triglycerides
Ionis Pharmaceuticals has achieved a significant milestone by obtaining FDA approval for their groundbreaking therapy, Tryngolza, designed to combat a rare and fatal genetic disease. This therapy targets patients suffering from familial chylomicronemia syndrome...
Improved Stool-Based Colon Cancer Test by Exact Sciences Receives FDA Approval
Exact Sciences recently received FDA approval for an improved version of their stool-based screening test for colon cancer. This new test, called Cologuard Plus, is designed to reduce the number of cancer-free patients who...
Needle-Free Nasal Spray FDA-Approved for Anaphylaxis Treatment
The Food and Drug Administration recently gave its approval for ARS Pharmaceuticals' needle-free nasal spray to be used as an emergency treatment for severe allergic reactions, also known as anaphylaxis. This nasal spray, named...
New Hope for Endometrial Cancer Patients with FDA-Approved Immunotherapy
The U.S. Food and Drug Administration (FDA) recently approved a new drug for certain adult patients with endometrial cancer. The drug, called Jemperli (dostarlimab-gxly), is an immunotherapy-based drug made by British pharmaceutical company GSK....
FDA Requests Further Research before Approving MDMA Therapy
The Food and Drug Administration (FDA) recently declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), citing insufficient data to support its use. The FDA requested additional clinical trials to...
FDA Approves Needle-Free Nasal Spray for Anaphylaxis Treatment
The Food and Drug Administration recently approved a new needle-free nasal spray from ARS Pharmaceuticals for the treatment of severe allergic reactions, including anaphylaxis. The spray, called Neffy, offers an alternative to traditional autoinjectors...
New FDA-Approved Overdose-Reversal Medication by Purdue Pharma
Purdue Pharma, infamous for its role in the opioid crisis, has received FDA approval for a new auto-injector device designed to reverse opioid overdoses. The device, known as Zurnai, uses nalmefene, a potent version...