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TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-World Data.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
 
 
TXT 20 Drugs Not Withdrawn Over Safety/Efficacy [86 Words] [ Price : $8.95]
Federal Register notice: FDA determines that 20 listed drug products were not withdrawn from sale due to safety or effectiveness issues.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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
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