FDA News

FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic Caplyta for Treatment of Schizophrenia in Adults

NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company …

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Karyopharma Submits NDA to the FDA for Xpovio for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NEWTON, Mass., Dec. 23, 2019 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for XPOVIO® (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) …

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FDA Approves Allergan’s Ubrelvy for the Acute Treatment of Migraine with or Without Aura in Adults

DUBLIN, Dec. 23, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for UBRELVY™ (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVY™ is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for …

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Biomarin Submits Valoctocogene Roxaparvovec BLA to the FDA for Treatment of Hemophilia A

SAN RAFAEL, Calif., Dec. 23, 2019 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.  Subject to completion of the …

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Seattle Genetics Submits Tucatinib NDA to the FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or …

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FDA Grants Accelerated Approval to Enhertu for the Treatment of HER2 Positive Unresectable Metastatic Breast Cancer

TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2 positive breast …

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ViiV Healthcare Receives Complete Response Letter from the FDA for its Investigational Long-Acting HIV Regimen

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically …

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FDA Grants Avatrombopag Orphan Drug Designation for the Treatment of Chemotherapy-Induced Thrombocytopenia

STOCKHOLM, Dec. 21, 2019 /PRNewswire/ — Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™) has been granted Orphan Drug Designation[1] (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treatment of Chemotherapy-Induced Thrombocytopenia (CIT). Enrollment remains ongoing for the …

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FDA Approves Merck’s Ervebo, the First-Approved Vaccine for Prevention of Ebola Virus Disease

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 approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced er-VEE-boh) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The duration of …

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Amgen and Allergan Submit BLA to the FDA for ABP 798, a Biosimilar Candidate to Rituxan

THOUSAND OAKS, Calif., Dec. 19, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA. “The U.S. filing …

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