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Welcome to FDAweb Pay Per View Search our 70,551 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   ChemoCentryx Vasculitis Drug Approved [215 Words] [ Price : $8.95] FDA approves a ChemoCentryx NDA for Tavneos (avacopan) as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis in combination with standard therapy. 10/08/2021     Panel Unanimously Backs Takeda Cytomegalovirus Drug [149 Words] [ Price : $8.95] FDA’s Antimicrobial Drugs Advisory Committee votes 17-0 to recommend approval of Takeda’s maribavir to treat cytomegalovirus infection in the post-transplant setting. 10/08/2021     Labeling Recommendations for Surgical Staplers [59 Words] [ Price : $8.95] Federal Register notice: FDA announces a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations. 10/08/2021     Surgical Staplers Up-classified to Class 2 [164 Words] [ Price : $8.95] Federal Register notice: FDA issues a final order to reclassify surgical staplers for internal use from Class 1 into Class 2 and subject to premarket review. 10/08/2021     FDA Outlines Novel Excipient Pilot Program [266 Words] [ Price : $8.95] FDA outlines a new pilot program on using novel excipients with the intent to increase their use in drug development, especially if they have potential public health benefits. 10/08/2021     Janssen Stelara Juvenile Psoriatic Arthritis sBLA [202 Words] [ Price : $8.95] Janssen Pharmaceutical files a supplemental BLA for Stelara (ustekinumab) for treating pediatric patients aged five years and older with juvenile psoriatic arthritis. 10/08/2021     Genentech ‘Breakthrough’ Status on Alzheimer’s Drug [208 Words] [ Price : $8.95] FDA grants Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients. 10/08/2021     Warning on Needle-free Devices for Dermal Fillers [187 Words] [ Price : $8.95] FDA issues a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and facial fillers. 10/08/2021     FDA Reclassifies Surgical Staplers, Staples [2948 Words] [ Price : $8.95] FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days. 10/07/2021     De Novo Sought for Fibromyalgia Neuromodulator [200 Words] [ Price : $8.95] NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults. 10/07/2021       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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