-
Regenxbio Announces FDA Clearance of IND for Trial of Diabetic Retinopathy Treatment
americanpharmaceuticalreview
August 26, 2020
Regenxbio announced the clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR).
-
AbbVie Submits Regulatory Application to FDA for Rinvoq for Ankylosing Spondylitis
americanpharmaceuticalreview
August 26, 2020
AbbVie has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for Rinvoq™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with ...
-
Lupin gets US FDA approval for generic Albuterol Sulphate MDI
expresspharma
August 26, 2020
It is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.
-
US FDA denies approval for Tricida’s Veverimer
expresspharma
August 26, 2020
Veverimer (TRC101), a non-absorbed, orally-administered polymer, is designed to treat metabolic acidosis in patients with chronic kidney disease (CKD).
-
Amneal gets US FDA approval for Lidocaine Patch
expresspharma
August 26, 2020
Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for a generic version of Lidocaine Patch, 5%.
-
FDA Approves New Kyprolis, Darzalex Combination Regimen
americanpharmaceuticalreview
August 25, 2020
Amgen announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the Kyprolis® (carfilzomib) U.S. prescribing information to include its use in combination with Darzalex® (daratumumab) plus dexamethasone (DKd) in two dosing ...
-
FDA Approves Lampit for Chagas Disease in Pediatric Patients
americanpharmaceuticalreview
August 25, 2020
The U.S. Food and Drug Administration (FDA) approved Lampit (nifurtimox) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi, in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg).
-
FDA Approves Romark Facility in Puerto Rico
contractpharma
August 25, 2020
The facility is equipped to produce tablets, powders and other oral solid dosage forms.
-
FDA issues EUA to convalescent plasma for COVID–19 treatment
expresspharma
August 25, 2020
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalised patients.
-
FDA issues emergency use authorization for convalescent plasma as potential promising COVID-19 treatment
worldpharmanews
August 24, 2020
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency's ongoing efforts to fight COVID-19.