Highly Significant Results In Ph 3 Study Of Ameluz®-Photodynamic Therapy (PDT) in Superficial Basal Cell Carcinoma (sBCC) Announced
“We are delighted that these highly significant results mirror those found in the European studies,” stated Dr. Hermann Luebbert, CEO and Chairman of Biofrontera. He added, “Once we finish the one-year follow up phase in December, we will be in a position to submit our dossier to the FDA around the end of Q2 / early Q3 of 2025”.
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“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
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“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us