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WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently granted accelerated approval to Epkinly (epcoritamab-bysp), a new treatment option for adults with relapsed or refractory follicular lymphoma (FL). This …
FDA Grants Accelerated Approval to New Treatment for Relapsed Follicular Lymphoma Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently granted accelerated approval for a new treatment combination for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). …
FDA Grants Accelerated Approval to New Colorectal Cancer Treatment Read More
WASHINGTON, D.C. — The FDA on Wednesday granted full approval to the drug selpercatinib, marketed as Retevmo, for treating advanced thyroid cancer in both adults and children aged 2 and …
FDA Grants Full Approval to Retevmo for Advanced Thyroid Cancer Read More WASHINGTON, D.C. — In a significant advancement for patients with rare blood diseases, the U.S. Food and Drug Administration (FDA) has given its nod to Bkemv (eculizumab-aeeb), the first interchangeable …
FDA Approves Bkemv, A Potentially Game-Changing Treatment for Rare Blood Diseases Read More
HORSHAM, PA — In a significant medical breakthrough, Johnson & Johnson recently announced FDA’s approval of CARVYKTI® for the treatment of adult patients with multiple myeloma. This approval marks a …
FDA Approves Johnson & Johnson’s Innovative, Immuno-Targeted Multiple Myeloma Therapy, CARVYKTI Read More
NEWTOWN SQUARE, PA — In recent developments from the pharmaceutical industry, ArriVent BioPharma Inc. (Nasdaq: AVBP), a notable player in the arena of breakthrough cancer therapy, has seen a transformative …
ArriVent BioPharma Unveils Promising Developments and Strong Financial Performance in 2023 Read More
PLYMOUTH MEETING, PA — The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Harmony Biosciences Holdings, Inc.’s (Nasdaq: HRMY) pitolisant for the treatment of Prader-Willi syndrome …
Harmony Biosciences Secures FDA Orphan Drug Designation for Pitolisant in Prader-Willi Syndrome Treatment Read More
PHILADELPHIA, PA — The biotech firm Cabaletta Bio, Inc. (Nasdaq: CABA) has secured an Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy, …
FDA Awards Orphan Drug Designation to Cabaletta’s Innovative Myositis Therapy Read More
WAYNE, PA — Neuraptive Therapeutics Inc. recently announced that its novel treatment for peripheral nerve injury, NTX-001, has received Orphan Drug Designation from the United States Food and Drug Administration …
Neuraptive Therapeutics Earns FDA Orphan Drug Designation for Novel Peripheral Nerve Injury Treatment Read More The U.S. Food and Drug Administration (FDA) recently approved Ogsiveo (nirogacestat) tablets for the systemic treatment of adult patients with progressing desmoid tumors, marking it as the first drug to …
FDA Approves Ogsiveo, First-Ever Drug for Treatment of Desmoid Tumors Read More