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TXT Heron Submits PONV Drug NDA to FDA [2655 Words] [ Price : $8.95]
Heron submits an NDA for its HTX-019 injectable emulsion to prevent postoperative nausea and vomiting in adults.
11/18/2021
 
 
TXT Lunit AI Breast Cancer Detector Cleared [127 Words] [ Price : $8.95]
FDA clears a Lunit 510(k) for its Insight MMG, an artificial intelligence application for breast cancer detection.
11/18/2021
 
 
TXT Reminder on Leadless Pacing System Complications [2725 Words] [ Price : $8.95]
FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker systems.
11/18/2021
 
 
TXT FDA Approves New Keytruda Indication [2683 Words] [ Price : $8.95]
FDA approves a new renal cell carcinoma indication for Merck’s Keytruda.
11/18/2021
 
 
TXT FDA Says Its Pharmacists Can Help Consumers [2651 Words] [ Price : $8.95]
FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.
11/18/2021
 
 
TXT Explore Nitrosamine Impurity Mitigation Strategies: FDA [2695 Words] [ Price : $8.95]
FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.
11/18/2021
 
 
TXT FDA: We Need 55 Years for Pfizer Vaccine Info Request [2943 Words] [ Price : $8.95]
FDA tells a Texas federal court it needs until 2076 to respond to a Public Health and Medical Professionals for Transparency request for information on the Pfizer Covid-19 vaccine.
11/18/2021
 
 
TXT FDA OKs Resumption of Enrollment in Masitinib Trial [2656 Words] [ Price : $8.95]
FDA says AB Science can resume enrollment of ALS patients in a Phase 3 study of masitinib.
11/18/2021
 
 
TXT Fast Track for Zentalis Uterine Carcinoma Drug [2665 Words] [ Price : $8.95]
FDA grants fast track designation to a Zentalis investigative drug for uterine serous carcinoma.
11/17/2021
 
 
TXT Alzheimer’s Treatment, Diagnostic Registry Launched [2811 Words] [ Price : $8.95]
The Alzheimer’s Association and other stakeholders are launching a national registry for Alzheimer’s diagnostic and treatment information.
11/17/2021
 
 
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