Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA approves SpringWorks’ Ogsiveo (Nir

Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to

FDA approves Astra Zeneca’s TRUQAP (ca

AstraZeneca’s TRUQAP (New Molecule Capivasertib) in combination with Faslodex (Fulvestrant) has been approved in the

Ascendis Pharma announces European appro

Danish Pharma firm Ascendis Pharma announced the European Commission approval for palopegteriparatide (Yorvipath), for treatment

USFDA approves Santhera’s New Molecula

Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy

FDA Approves Pfizer’s VELSIPITY  (etr

Velsipity (etrasimod) is an oral, once-daily, 2mg dose medication for adults with moderately to severely

FDA approves NCE Gepirone (EXXUA) for Ma

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company announced approval of Exxuaâ„¢ (gepirone hydrochloride extended-release tablets)

FDA approves Cantharidin (YCANTH™,  V

Verrica Pharmaceuticals Inc. is a dermatology therapeutics company developing medications for skin diseases requiring medical

FDA on Friday approved Lexicon’s heart

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