FDA News

Aurinia Completes Rolling Submission of Voclosporin NDA to the FDA for Treatment of Lupus Nephritis

VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the completion of the rolling submission of a New Drug Application (“NDA”) to the United States Food and Drug Administration …

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FDA Approves Takeda’s Alunbrig as a First-Line Treatment for Patients Diagnosed with Rare and Serious Form of Lung Cancer

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) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the …

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FDA Grants Orphan Drug Designation to Enhertu for Treatment of Gastric Cancer

TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Orphan Drug Designation (ODD) in the U.S. for the treatment of patients with gastric cancer, including gastroesophageal junction cancer. The U.S. Food and Drug Administration (FDA) grants ODD to medicines intended for …

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Passage Bio Receives Rare Pediatric Disease Designation from the FDA for PBGM01 for Patients with GM1 Gangliosidosis

PHILADELPHIA, May 21, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc. (NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to PBGM01 broadly for the treatment …

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FDA Approves Lynparza for Treatment of HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada) today announced that LYNPARZA® (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic …

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FDA Grants Priority Review to Eiger’s NDA for Zokinvy for Treatment of Progeria and Progeroid Laminopathies

PALO ALTO, Calif., May 19, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for accelerated review of Zokinvy™ (lonafarnib) for …

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ArcherDX Receives FDA Breakthrough Device Designation for its NGS Device Under Development as a CDx to Detect NTRK Gene Fusions

BOULDER, Colo., May 19, 2020 /PRNewswire/ — ArcherDX, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next-generation sequencing (NGS) device under development as a companion diagnostic (CDx) to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions that lead to the …

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Genentech’s Tecentriq Receives FDA Approval as a First-Line Monotherapy for Certain People with Metastatic NSCLC

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) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 …

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FDA Grants Breakthrough Therapy Designation to Enhertu for Treatment of HER2-Mutant Metastatic Non-Small Cell Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo Company, Limited’s (Daiichi Sankyo) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy. …

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FDA Grants Full Approval of Deciphera’s Qinlock for Treatment of Fourth-Line Gastrointestinal Stromal Tumor

WALTHAM, Mass.–(BUSINESS WIRE)–Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the U.S. Food and Drug Administration (FDA) has approved QINLOCK™ (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. The FDA previously granted Breakthrough Therapy …

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