Glenmark receives 6 USFDA observations for Baddi facility Roshni Dhar24 Jun 2022 6:00 PM ISTDrugmaker, Glenmark Pharmaceuticals Ltd, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with six...
Novel novel mesh plug effective for treatment of sidewall brain aneurysm Dr. Kamal Kant Kohli15 May 2022 9:30 PM ISTOAK BROOK: A novel mesh plug that has been traditionally used to treat brain aneurysms occurring where the blood vessels branch out was found to be...
USFDA issues 3 observations for Zydus Lifesciences's Vadodara plant MD Bureau11 March 2022 2:36 PM IST"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our...
FDA approves Empagliflozin for heart failure despite contrary results Dr. Nandita Mohan3 March 2022 6:45 PM ISTTrials are being conducted to prevent cardiac death, The US Food and Drug Administration (FDA) has approved an expanded heart failure (HF) indication...
Semaglutide an effective alternative drug option to treat obesity MD Editorial Team24 Feb 2022 9:00 AM ISTObesity is a seriously neglected disease that is factually a multifactorial chronic disease affecting 650 million adults globally. It is associated...
Pfizer COVID booster shot for 12 to 15-year-olds backed by USFDA Medical Dialogues Bureau4 Jan 2022 9:45 AM ISTThe regulatory decisions come as COVID cases surge due to the Omicron variant, with health authorities warning that its high transmissibility could...
Seglentis approved for acute pain Roshni Dhar26 Oct 2021 4:44 PM ISTThe US Food and Drug Administration (FDA) has approved Seglentis a combination of celecoxib and tramadol hydrochloride for severe acute pain in...
FDA Approves IV Formulation of Uptravi for Pulmonary Arterial Hypertension Hina Zahid4 Aug 2021 3:46 PM ISTUSA: The US Food and Drug Administration (FDA) has approved intravenous (IV) formulation of Uptravi (selexipag) injection for the treatment of...
Enfortumab vedotin-ejfv receives FDA approval and expanded indication for urothelial cancer Medha Baranwal14 July 2021 12:00 AM ISTUSA: Padcev (enfortumab vedotin-ejfv) has received the FDA's (Food and Drug Administration) regular approval for the treatment of adults with locally...
StrataGraft for treatment of thermal burns gets FDA approval Hina Zahid16 Jun 2021 10:45 AM ISTUSA: The U.S. Food and Drug Administration has given approval to StrataGraft for the treatment of adult patients with thermal burns. Thermal burns are...
First treatment for hypoplasminogenemia receives FDA approval Hina Zahid8 Jun 2021 10:40 AM ISTUSA: The U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type...
Tramadol gets rejected by FDA owing to safety concerns Medha Baranwal15 Oct 2020 11:25 PM ISTUSA: The US Food and Drug Administration (FDA) has issued a complete response letter ("CRL") regarding the New Drug Application ("NDA")...
