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Welcome to FDAweb Pay Per View Search our 70,821 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Next >>   Alkermes Gets Fast Track on Ovarian Cancer Therapy [87 Words] [ Price : $8.95] FDA grants Alkermes a fast track designation for nemvaleukin alfa, an engineered interleukin-2 variant immunotherapy for use in combination with Merck’s Keytruda in treating platinum-resistant ovarian cancer. 10/25/2021     Advisory Committee to Hear Avenue Dispute Resolution [325 Words] [ Price : $8.95] CDER’s Office of New Drugs says an advisory committee meeting will be convened to review an Avenue Therapeutics dispute resolution request regarding its twice-rejected intravenous tramadol NDA, indicated for treating pain. 10/25/2021     Panel to Vote on Ischemic Stroke System [87 Words] [ Price : $8.95] Federal Register notice: FDA announces a 12/10 meeting of the Medical Devices Advisory Committee’s Neurological Devices Panel that will review a BrainsGate PMA for its Ischemic Stroke System. 10/25/2021     Biocon Malaysian Plant Gets 6-item FDA-483 [76 Words] [ Price : $8.95] FDA posts a six-observation Form FDA-483 after inspecting a Biocon drug substance manufacturing facility in Malaysia. 10/25/2021     FDA Information Page on Endometrial Ablation [215 Words] [ Price : $8.95] CDRH creates a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding. 10/25/2021     Guide on Submitting Real-world Data [78 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. 10/22/2021     20 Drugs Not Withdrawn Over Safety/Efficacy [86 Words] [ Price : $8.95] Federal Register notice: FDA determines that 20 listed drug products were not withdrawn from sale due to safety or effectiveness issues. 10/22/2021     Hold on Tryp Therapeutics Eating Disorder Study [170 Words] [ Price : $8.95] FDA issues a clinical hold against Tryp Therapeutics and a Phase 2a study evaluating its psilocybin for eating disorders. 10/22/2021     PD-1 Inhibitor BLA Yanked After Keytruda Approval [214 Words] [ Price : $8.95] Agenus withdraws a BLA for balstilimab after FDA urged it to do so following Merck’s recent full approval for pembrolizumab for treating cervical cancer. 10/22/2021     FDA Approves Large Photodynamic Therapy Light [99 Words] [ Price : $8.95] FDA approves Biofrontera’s BF-RhodoLED XL, a red-light source for photodynamic therapy and its combination use with the company’s Ameluz gel for treating mild and moderate actinic keratoses on the face and scalp. 10/22/2021     << Prev  9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28  Next >>

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