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...
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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...
Washington DC — FDA announced a pilot program, Support for clinical Trials Advancing Rare disease Therapeutics (START), intended to support development of novel drug and biological products for rare diseases. The agency is establishing a pilot program for a limited number of sponsors, intended to allow for more regular communication...
Parc d’Innovation, Illkirch, France – Transgene (Euronext Paris: FR0005175080) announces that it recently met with the U.S. Food and Drug Administration (FDA) for an end of Phase II meeting when results of its TG4010 controlled phase IIb clinical trial in non-small-cell lung cancer (NSCLC) were reviewed. As per the minutes...
VANCOUVER, BC – Bold Therapeutics, a clinical-stage biopharmaceutical company, is announcing that the U.S. Food & Drug Administration (FDA) has granted BOLD-100 an Orphan Drug Designation (ODD) in the treatment of gastric (stomach) cancer. BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR)...
Basel – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on...
SHANGHAI, China — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous...
HENDERSON, Nev. – Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations....
Tokyo, Japan – The FDA on Tuesday approved the use of Takeda’s HyQvia (immune globulin infusion 10% with recombinant human hyaluronidase) as a treatment for chronic inflammatory demyelinating polyneuropathy. With the label expansion, HyQvia can now be given as a maintenance therapy to prevent the relapse of neuromuscular disability and...