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.

Andrea 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.

The 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.

A 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.

Wrapping 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