FDA acceptance propels Tonix Pharmaceuticals’ TNX-102 SL towards fibromyalgia treatment approval
Tonix Pharmaceuticals Holding Corp. has achieved a pivotal milestone with the FDA acceptance announcement for its New Drug Application (NDA) of TNX-102 SL, a novel ... Read More
Galderma’s nemolizumab sets new standard in prurigo nodularis treatment with OLYMPIA 1 trial success
Galderma’s latest clinical trial has unveiled a significant breakthrough in treating prurigo nodularis, a chronic neuroimmune skin condition characterized by relentless itching and thickened skin ... Read More
Applied Therapeutics stock collapses as FDA rejects govorestat for galactosemia treatment
Shares of Applied Therapeutics, Inc. (Nasdaq: APLT) suffered a dramatic decline after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) ... Read More
AbbVie’s schizophrenia treatment crumbles, boosting Bristol Myers Squibb to the top
Bristol Myers Squibb's stock surged dramatically after pharmaceutical giant AbbVie announced disappointing results in its recent clinical trials for a promising schizophrenia drug. The development ... Read More
Granules India gains key FDA approval for Unit V facility, marking major compliance milestone
Hyderabad-based Granules India Limited has achieved a significant regulatory milestone, securing an Establishment Inspection Report (EIR) with a “No Action Indicated” (NAI) status from the ... Read More
Hims & Hers’ earnings soar while GLP-1 drug crisis deepens—what this means for investors
Hims & Hers Health Inc. saw its stock surge following a robust quarterly earnings report, which showcased significant growth in revenue and subscriber numbers. Despite ... Read More
Medtronic’s Symplicity Spyral RDN catheter secures CMS approval for boosted Medicare access
The US Centers for Medicare & Medicaid Services (CMS) has granted Medtronic plc, a global healthcare technology leader, transitional pass-through (TPT) payment status for its ... Read More
Recce Pharmaceuticals secures phase II trial safety approval for breakthrough R327G treatment
Recce Pharmaceuticals Limited recently announced significant progress in its phase II clinical trial for RECCE 327 Topical Gel (R327G), an innovative treatment for acute bacterial ... Read More
vTv Therapeutics and OnKure part ways, dissolving pivotal cellular drug agreement
vTv Therapeutics, a clinical-stage biopharmaceutical company known for its innovative approach in diabetes treatment, and OnKure Therapeutics, an oncology-focused pharmaceutical company, have announced the termination ... Read More
FDA greenlights Medtronic’s dual-energy ablation—could this be the future of AFib treatment?
Medtronic has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting approval for its Affera Mapping and Ablation System, including the ... Read More