Alembic Pharma gets 4 observations from USFDA for Panelav facility Medical Dialogues Bureau17 March 2020 10:57 AM ISTGujarat: Alembic Pharmaceuticals has announced that the US Food and Drug Administration (USFDA) has conducted an inspection at Alembic...
Roche gets USFDA Emergency Use Authorization for its Cobas SARS-CoV-2 Test Medical Dialogues Bureau15 March 2020 12:49 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2...
Alkem Laboratories receives EIR from USFDA for Baddi facility Medical Dialogues Bureau15 March 2020 9:15 AM ISTNew Delhi: Drug firm Alkem Laboratories on Friday said the US health regulator has issued an establishment inspection report (EIR) for its...
SMS Pharmaceuticals gets EIR from USFDA for Kandivalasa facility Medical Dialogues Bureau13 March 2020 2:23 PM ISTIndia: SMS Pharmaceuticals has announced the successful closure of inspection with the receipt of Establishment Inspection Report (EIR) from the...
Roche gets USFDA nod for CINtec PLUS Cytology test for cervical cancer Medical Dialogues Bureau12 March 2020 12:12 PM ISTCINtec PLUS Cytology provides definitive information about which HPV-positive women may benefit most from immediate referral to colposcopy versus...
Biocon, Mylan win patent rights for Insulin Glargine Device against Sanofi Medical Dialogues Bureau12 March 2020 11:29 AM ISTInsulin Glargine is a long-acting insulin used to treat adults with Type 2 diabetes and adults and paediatric patients with Type 1 diabetes for the...
USFDA completes inspection of Natco's Kothur formulation facility Medical Dialogues Bureau11 March 2020 1:07 PM ISTHyderabad: Natco Pharma Limited has announced the completion of a Pre-approval inspection from the United States Food and Drug Administration (USFDA)...
FDA, FTC Warn Seven Companies Selling Fraudulent Products to Treat COVID-19 Medical Dialogues Bureau11 March 2020 11:00 AM ISTThe FDA and FTC jointly issued warning letters to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC doing business as N-Ergetics, GuruNanda,...
USFDA Accepts Biocon, Mylan's application for review of Proposed Biosimilar of Bevacizumab Medical Dialogues Bureau10 March 2020 1:15 PM ISTBiocon Ltd. and Mylan N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA)...
Urovant Sciences gets USFDA nod for once-daily 75 mg vibegron for overactive bladder Medical Dialogues Bureau9 March 2020 12:26 PM ISTIRVINE -Urovant Sciences has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application...
TG Therapeutics gets USFDA Orphan Drug Designation for follicular lymphoma drug Umbralisib Medical Dialogues Bureau9 March 2020 10:45 AM ISTNew York - TG Therapeutics, Inc.today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to umbralisib,...
Acacia Pharma gets USFDA nod of BARHEMSYS® (amisulpride) for Treatment, Prevention of PONV Medical Dialogues Bureau8 March 2020 10:00 AM ISTThe approval for BARHEMSYS covers the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who...
