The U.S. Food and Drug Administration issued a Complete Response Letter for Alkermes’ New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar 1 disorder, and a CRL for Adamis Pharmaceuticals’ NDA for the high-dose naloxone injection product ZIMHI for the treatment of opioid overdose.
Heron Therapeutics Inc.’s New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain.
Shares of Avenue Therapeutics plunged in trading after the company announced the U.S. Food and Drug Administration rejected the New Drug Application for intravenous tramadol over safety concerns.
3 Ways Remote Site Monitoring Can Increase Regulatory Compliance for Your Study
Business, Clinical Researchers, Clinical Trials, Compliance, Contract Research Organization (CRO), Coronavirus Disease 2019 (COVID-19), FDA, Life Sciences, New Drug Application (NDA), Premarket Approval Application (PMA), Software, TechnologyAndrea Bastek – Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research – discusses three ways in which sponsors and CROs can increase compliance with a purpose-built, site-centric, remote access platform.
FDA Action Alert: Aquestive, Eton and Mesoblast
Adrenal Glands, Adrenal Insufficiency, Business, Clinical Trials, Congenital Adrenal Hyperplasia (CAH), Epilepsy, FDA/Regulatory, Glands, New Drug Application (NDA), Oncologic Drugs Advisory Committee (ODAC), PDUFA, Pediatric, Quarterly results, R&D, Seizure ClustersThe U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
FDA Action Alert: PTC and Roche, Lipocine, Incyte and Morphosys, and BMS
Adults, Babies, Children, Clinical Trials, Complete Response Letter, FDA, FDA/Regulatory, NDA Resubmission, New Drug Applications, PDUFA, Priority Review, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), Spinal Muscular Atrophy (SMA), Survival motor neuron 1 (SMN1) gene, Survival Motor Neuron 2 (SMN2) GeneA look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
GlaxoSmithKline’s HIV business ViiV is within weeks of resubmitting the request for approval of the long-acting injection Cabenuva to the U.S. drug regulator.
FDA Action Alert
Acromegaly, Blockbusters, Checkpoint Inhibitors, Clinical Trials, Cutaneous Squamous Cell Carcinoma (CSCC), Diffuse Large B-Cell Lymphoma (DLBCL), Dravet syndrome, FDA/Regulatory, NDA Resubmission, New Drug Applications, Non-alcoholic steatohepatitis (NASH), Postoperative Pain, R&D, Seizures, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), TherapeuticsWrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Myovant announced additional data from the company’s Phase III HERO trial of once-daily, oral relugolix in advanced prostate cancer.
A new report released by GlobalData showed that there was a 16 percent decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration during 2019