The U.S. Food and Drug Administration approved Heron Therapeutics Inc.’s Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
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.
Acadia Pharmaceuticals is adding a novel pain portfolio to the company’s pipeline through the acquisition of Texas-based CerSci Therapeutics for $52.5 million.
Heron Therapeutics Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding the company’s New Drug Application for HTX-011 for the management of postoperative pain.
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.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
Heron Therapeutics Inc. announced positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty surgery received the investigational agent HTX-011 together with a scheduled postoperative regimen of generic, oral analgesics (acetaminophen and celecoxib).
Heron Therapeutics Inc. resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the commercial-stage biotechnology company’s HTX-011, an investigational agent for the management of postoperative pain.
Heron Therapeutics Inc. announced that the company received a Complete Response Letter from the U.S. Food and Drug Administration on April 30, 2019 regarding the New Drug Application for HTX-011 for the management of postoperative pain.
