OSAKA, Japan and CAMBRIDGE, Massachusetts – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient,...
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NEW YORK, NY — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND...
Washington DC – The FDA has granted approval to frontline toripalimab-tpzi (Loqtorzi) plus cisplatin and gemcitabine for adult patients with metastatic or locally advanced nasopharyngeal carcinoma (NPC), as well as single-agent toripalimab for recurrent, unresectable, or metastatic disease that has progressed on or following prior chemotherapy, according to a press...
WASHINGTON DC – Following in the footsteps of its U.K. counterpart, the FDA on Friday approved the first-ever CRISPR-based gene editing therapy in the form of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) for sickle cell disease, while also granting approval to bluebird bio’s lovo-cel, which will carry the...
MUMBAI, India and PRINCETON, N.J. — Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, “Sun Pharma”)) today announced the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic CSCC...
THOUSAND OAKS, Calif. — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment...
Boston, Mass. – Vorasidenib has been approved by the U.S. Food and Drug Administration (FDA) for patients with Grade 2 gliomas with IDH1 or IDH2 mutations. Based on evidence from the INDIGO clinical trial, a global phase 3, double-blinded, randomized clinical trial, vorasidenib more than doubled progression-free survival and delayed the need for...
Washington, DC – The FDA’s safety probe of CAR-T therapies has resulted in a call to add a class-wide boxed warning to these medicines, alerting patients and prescribers of their potential risk of secondary T-cell malignancies. All six commercial CAR-T therapies will be affected, including J&J’s Legend Biotech-partnered Carvykti (ciltacabtagene...
MIAMI, Florida — DermaSensor Inc. announces FDA clearance for its real-time, non-invasive skin cancer evaluation system. For the first time, the 300,000 primary care physicians in the U.S. can now be equipped to provide quantitative, point-of-care testing for all types of skin cancer. Better identifying skin cancer in a primary...
MELBOURNE, Australia — Amplia Therapeutics Limited, is pleased to announce that the U.S. FDA have cleared Amplia’s IND application for a trial of Amplia’s best-in-class focal adhesion kinase (FAK) inhibitor narmafotinib in pancreatic cancer. The proposed trial will explore the safety, tolerability and efficacy of a combination of narmafotinib with...