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FDA Approves Updated Label for Miach Orthopaedics’ BEAR® Implant to Include Significantly Lower Risk of Osteoarthritis
3+ hour, 13+ min ago (90+ words) 6x Higher Rate of Post-Traumatic Osteoarthritis (PTOA) for ACL Reconstruction Compared to BEAR Implant Observed in BEAR I and II Studies About The BEAR" Implant In patients 14 years and older who have an ACL injury with concomitant knee injuries, ACL restoration…...
Surf Therapeutics Announces Early Feasibility Study (EFS) To Advance Non-Invasive Approach to Neuromodulation for Rheumatoid Arthritis
6+ day, 4+ hour ago (363+ words) Surf Therapeutics Announces Early Feasibility Study (EFS) To Advance Non-Invasive Approach to Neuromodulation for Rheumatoid Arthritis'BioSpace Surf Therapeutics Announces Early Feasibility Study (EFS) To Advance Non-Invasive Approach to Neuromodulation for Rheumatoid Arthritis "The launch of our EFS trial represents an…...
Biosplice Announces the Submission of its New Drug Application (NDA) to the FDA for Lorecivivint (LOR) to Treat Knee Osteoarthritis
1+ week, 2+ day ago (736+ words) Biosplice Announces the Submission of its New Drug Application (NDA) to the FDA for Lorecivivint (LOR) to Treat Knee Osteoarthritis'BioSpace Biosplice Announces the Submission of its New Drug Application (NDA) to the FDA for Lorecivivint (LOR) to Treat Knee Osteoarthritis…...
Lexicon Backs Phase III Go Decision for Non-Opioid Pain Med With Post-Hoc Analysis
3+ mon, 3+ week ago (199+ words) Lexicon Pharmaceuticals announced in March that its non-opioid pain medicine pilavapadin will push forward to Phase III testing, despite falling short of significant pain reduction in a mid-stage study. On Wednesday, the Texas-based biotech unveiled follow-up data to support its…...
Rosnilimab Shows Promise as a Potential Next-Generation RA Therapy
4+ mon, 7+ hour ago (724+ words) Investigational rosnilimab, a selective depleter of pathogenic T cells, shows promise as a novel treatment for moderate-to-severe rheumatoid arthritis, a chronic autoimmune disease that primarily affects the joints, causing pain, swelling and inflammation.1 The U.S. RA market is valued at more…...
FDA Looks to Streamline Development of Non-Opioid Painkillers
4+ mon, 4+ day ago (298+ words) The FDA has signaled its openness to accelerating the development of new, non-opioid analgesic treatments for chronic pain in a new draft guidance. But for non-opioid painkillers for chronic pain, the agency is considering allowing the use of just one…...
Tonix Wins Approval For First New Fibromyalgia Drug in Over 15 Years
4+ mon, 4+ week ago (260+ words) After more than a decade of waiting for a new therapy, patients with fibromyalgia will now have access to an oral pill in the form of Tonix Pharmaceuticals" Tonmya, which the FDA signed off on this past Friday. Given sublingually'under…...
Vertex's Journavx Changes the Pain Treatment Landscape But Opioids Here to Stay
10+ mon, 2+ week ago (1197+ words) When Vertex Pharmaceuticals won FDA approval for Journavx last month, it opened a new era in a therapeutic space recently fraught with suffering, controversy and thousands of avoidable deaths. Eighty million people in the U.S. suffer from acute pain every year,…...
Axsome’s Migraine Medicine Clears FDA Bar
11+ mon, 2+ week ago (379+ words) The FDA gave the greenlight to Axsome Therapeutics" Symbravo for the acute treatment of migraine, just hours before approving Vertex"s non-opioid analgesic Journavx for acute pain Thursday. According to the biotech, Symbravo"s approval opens up a novel multi-mechanistic…...
FDA Approves Vertex’s Journavx as First New Pain Drug in Decades
11+ mon, 2+ week ago (376+ words) A week after Purdue Pharma and the Sackler family agreed to pay $7.4 billion to settle lawsuits stemming from the company's opioid-based painkiller OxyContin, the FDA approved Vertex's suzetrigine as the first new mechanism for acute pain in more than 20 years'possibly…...
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