FDA News

FDA Grants Fast Track Designation to BioCryst’s BCX9930 for Treatment of Paroxysmal Nocturnal Hemoglobinuria

RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). According to the FDA, the purpose of the …

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FDA Approves Monjuvi in Combination with Lenalidomide for Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

PLANEGG, Germany & MUNICH & WILMINGTON, Del.–(BUSINESS WIRE)–MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell …

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FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity

STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, and pre-clinical nucleic acid-based therapeutic drug candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) …

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FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination …

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FDA Approves Stelara for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

HORSHAM, Pa., July 30, 2020  — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) as a treatment for pediatric patients (6-11 years of age) who struggle with the skin lesions or plaques associated with moderate to …

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AstraZeneca’s Tagrisso Granted Breakthrough Therapy Designation by the FDA for Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s TAGRISSO® (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The Food and Drug Administration’s (FDA) BTD is …

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FDA Grants Breakthrough Therapy Designation to Takeda’s Pevonedistat for Treatment of Higher-Risk Myelodysplastic Syndromes

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat, a first in class NEDD8-activating enzyme (NAE) inhibitor, could be …

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Merck Announces Two FDA Regulatory Milestones for Keytruda in Triple-Negative Breast Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted two new supplemental Biologics License Applications (sBLAs) for KEYTRUDA, Merck’s anti-PD-1 therapy. The FDA has accepted and granted priority review for a new sBLA …

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Imara’s IMR-687 Granted Fast Track Designation and Rare Pediatric Disease Designation for Treatment of Beta-Thalassemia

BOSTON, July 30, 2020 (GLOBE NEWSWIRE) — IMARA Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Rare Pediatric …

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Bristol Myers and bluebird bio Announce Submission of BLA to the FDA for Idecabtagene Vicleucel for Relapsed and Refractory Multiple Myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell …

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