Subcutaneous Delivery System for Treprostinil Cleared by FDA
The FDA has cleared the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also known as the RemUnity system.
All articles by Steve Duffy
Inhaled Molgramostim Granted Fast Track Status for Autoimmune Pulmonary Alveolar Proteinosis
The FDA has granted Fast Track designation to Molgradex (molgramostim; Savara) for the treatment of autoimmune pulmonary alveolar proteinosis.
FDA: Seizures Reported Following E-Cigarette Use
The FDA is notifying the public that cases of seizures have been reported following the use of e-cigarettes.
FDA: Warning Letters Sent to Several Homeopathic Product Manufacturers Due to Quality Issues
The FDA has issued warning letters to four homeopathic drug manufacturers due to serious concerns over the quality of the products produced by these companies.
FDA Approves First Generic Versions of Ambrisentan, Adds New REMS Program
The Food and Drug Administration (FDA) has approved generic versions of the endothelin receptor antagonist Letairis (ambrisentan; Gilead) for the first time.
Recombinant Human Pentraxin-2 Gets Breakthrough Tx Designation for Idiopathic Pulmonary Fibrosis
A novel treatment for idiopathic pulmonary fibrosis, PRM-151, has been granted Breakthrough Therapy designation by the FDA.
FDA Warns Company Selling Misbranded Drugs With False Claims
The FDA issued a warning letter to NutraPharma, for selling false and misleading products that claim to treat addiction and chronic pain.
FDA to Review BLA for Oral Immunotherapy AR101 for Peanut Allergy
The Food and Drug Administration has accepted for review the Biologics License Application for AR101 (Aimmune Therapeutics) to reduce the risk of anaphylaxis following accidental exposure to peanut.
Clinical Outcomes Compared With Generics, Brand-Name Drugs for Chronic Conditions
An analysis found comparable clinical outcomes among patients who initiated generics vs those who were treated with brand-name drugs for chronic conditions.
FDA to Review Baloxavir Marboxil sNDA for Flu in Patients at High Risk for Complications
The FDA has accepted for review the sNDA for for Xofluza for the treatment of influenza in patients at high risk of complications.
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