Avobis Bio Receives FDA Fast Track Designation for AVB-114 Implantable Cell Therapy for Crohn's Perianal Fistulas
Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the ...
Jazz Pharmaceuticals plc: Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Dordaviprone addresses a significant unmet patient need for patients with rare, high-grade brain tumors- -Transaction to add near-term commercial opportunity to Jazz's pipeline- -Transaction ...
Medindia3d
Sigrid Therapeutics Secures U.S. Market Access for SiPore Technology Following SHINE Prediabetes Study Success
Sigrid Therapeutics (Sigrid) is excited to announce that it has secured U.S. market access for its proprietary SiPore� technology, following the success of the SHINE study, the largest of its kind in ...
The Manila Times1d
Anika Reports Fourth Quarter and Full Year 2024 Financial Results
Anika announced fourth quarter revenue from continuing operations of $30.6 million increasing 1% compared to the same period ...
The Manila Times2d
Bioventus Announces Fourth Quarter and Full Year 2024 Financial Results
Bioventus' full-year 2024 worldwide revenue totaled $573.3 million, an increase of 11.9% compared to the prior year. On an organic* basis, revenue increased 14.4%, driven by double-digit growth in ...
Medindia3d
Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy
Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and all key secondary ...
Kodiak Sciences Inc.: Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy
Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and ...
Food Safety News2h
Senate committee advances Makary to become new head of the FDA
Marty Makary is one step closer to becoming the head of the Food and Drug Administration. On March 13, the Senate Health, ...
FDA warns of scramble for workspaces and parking spots in Monday return to office
In Thursday's meeting, the director of the FDA's Center for Drug Evaluation and Research said plans for coming layoffs were ...
STAT15h
Trump’s picks to run FDA and NIH win approval from Senate’s health committee
Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug,” commented Gary S. Jacob, Ph.D., Chief Executive Officer ...
Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring 2025
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced ...