GSK Daprodustat bags USFDA review to treat anemia of CKD Ruchika Sharma20 April 2022 11:44 AM ISTDaprodustat, a HIF-PHI, belongs to a novel class of oral medicines indicated for the potential treatment of anemia of CKD in adult patients not on...
Lupin gets USFDA nod for generic equivalent of Vemlidy Tablets Ruchika Sharma18 April 2022 2:32 PM ISTThis product will be manufactured at Lupin's Nagpur facility in India.
USFDA successfully concludes inspection at Alkem Labs Taloja Bioequivalence Center Ruchika Sharma18 April 2022 1:15 PM ISTMaharashtra: Alkem Labs has recently announced the successful completion of the U.S. Food and Drug Administration (USFDA) inspection of its...
Zydus Lifesciences bags USFDA nod for Vitamin B12 injection Cyanocobalamin Ruchika Sharma18 April 2022 12:17 PM ISTThe drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat.
USFDA extends review of REGEN-COV to treat, prevent COVID-19: Regeneron Pharma Ruchika Sharma18 April 2022 10:00 AM ISTREGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies designed specifically to block infectivity of SARS-CoV-2 using...
Pfizer to seek USFDA nod for COVID booster for healthy 5- to 11-year-olds Ruchika Sharma17 April 2022 9:45 AM ISTThe Pfizer shots are the only vaccine available to US children.
Merck Pneumococcal vaccine gets USFDA Breakthrough Therapy Designation Ruchika Sharma16 April 2022 12:47 PM ISTThe Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of products intended for serious or...
Lupin bags USFDA okay for Desvenlafaxine ER tablets to treat depression Ruchika Sharma15 April 2022 12:01 PM ISTThe product will be manufactured at Lupin's facility in Goa, India.
Zydus Lifesciences to manufacture Sagent Pharma Caffeine Citrate Oral Solution Ruchika Sharma14 April 2022 11:36 AM ISTThe product is indicated for the short-term treatment of a breathing problem (Apenia) in premature infants.
USFDA warns online pharmacies illegally selling ADHD drug Adderall without prescriptions Ruchika Sharma14 April 2022 10:00 AM ISTAs noted in the warning letters, these websites sell amphetamine drug products, including Adderall, that are misbranded in violation of the Federal...
USFDA lifts partial clinical hold on studies evaluating magrolimab in combination with azacitidine: Gilead Sciences Ruchika Sharma12 April 2022 4:49 PM ISTFoster City: Gilead Sciences, Inc. has recently announced that the U.S. Food and Drug Administration (USFDA) has lifted the partial clinical hold...
Alembic Pharma arm gets USFDA nod for Lidocaine and Prilocaine Cream Ruchika Sharma12 April 2022 11:55 AM ISTLidocaine 2.5% and Prilocaine 2.5% cream is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous...
