FDA Approvals

Found 14,405 articles

• ADDING MULTIMEDIA — ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer

  1/18/2021

  Daiichi Sankyo Company, Limited and AstraZeneca’s ENHERTU® has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

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  FDA Approves Pfizer Med for Rare Form of Pediatric Non-Hodgkin Lymphoma

  1/15/2021

  The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.

• DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

  1/15/2021

  Accelerated approval of DARZALEX FASPRO®-based combination regimen supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder   [15-January-2021]   HORSHAM, Pa. , Jan. 15, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the

• Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis

  1/15/2021

  - DARZALEX FASPRO® Utilizing ENHANZE® Represents First and Only Approved Treatment for Patients with Newly Diagnosed AL Amyloidosis - - Accelerated Approval of DARZALEX FASPRO®-based Combination Regimen Supported by the PHASE 3 ANDROMEDA Study Demonstrating a Significantly Higher Hematologic Complete Response Rate in this Rare and Serious Blood Cell Disorder -

• Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 2020

  1/14/2021

  Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals.

• SML Genetree Receives FDA Emergency Use Authorization for Ezplex SARS-CoV-2 G Real-Time PCR Kit with Specimen Pooling Capability

  1/14/2021

  SML Genetree announced today that it has received Emergency Use Authorization (EUA) from the U.S. FDA for the use of its Ezplex SARS-CoV-2 G Kit, a molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 from nasopharyngeal swabs, oropharyngeal swabs and sputum specimens as well as for use in pooled pati

• FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy

  1/14/2021

  Today, the U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to control seizures in dogs with idiopathic epilepsy. Idiopathic epilepsy is a type of seizure disorder without a known cause

• Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults

  1/14/2021

  Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

• PerkinElmer SARS-CoV-2 RT-PCR Assay Receives FDA EUA for Asymptomatic Testing

  1/14/2021

  PerkinElmer, Inc. (NYSE:PKI) announced today that its PerkinElmer ® New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to test individuals without symptoms or other reasons to suspect COVID-19 infection. According to a new model f

• Orchard Therapeutics Announces OTL-200 Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by FDA for the Treatment of Metachromatic Leukodystrophy (MLD)

  1/14/2021

  Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OTL-200,

• Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

  1/14/2021

  Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties. Fast Track designat

• Vor Announces FDA Clearance of IND Application for VOR33

  1/14/2021

  Vor Biopharma , a clinical-stage cell therapy company pioneering engineered hematopoietic stem cell (eHSC) therapies combined with targeted therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for VOR33, an eHSC therapy candidate

• Vestibular First Achieves Diagnostic Breakthrough with FDA Clearance of Insight Infrared Video Goggles - Hosts Live Streaming Launch Event

  1/13/2021

  Vestibular First, a Philadelphia -based health-tech startup, is hosting a Live Streaming Launch Event on January 21st, 2021 for its patented Insight Infrared Video Goggles . These new FDA cleared goggles help clinicians cost-effectively differentiate various causes of dizziness and balance disorders. Vestibular First has identifi

• Leading BioSciences Announces FDA Fast Track Designation Granted to LB1148 for the Treatment of Postoperative Gastrointestinal Dysfunction Associated with Pediatric Cardiovascular SurgeryLBS expects to initiate a pivotal trial in 2021

  1/13/2021

  Leading BioSciences, Inc. (“LBS”), a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma, Inc. (Nasdaq: SNCA) to form Palisade Bio, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to LB1148 for the treatment of postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery.   “Even with high success ra

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  2021 Biopharma Update on the Novel Coronavirus: January 12

  1/12/2021

  Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 12, 2021.

• Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

  1/12/2021

  MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms.

• Liminal BioSciences Receives FDA Approval for its US-based Plasma Collection Center

  1/12/2021

   Liminal BioSciences Inc. (Nasdaq: LMNL) , a clinical-stage biopharmaceutical company, announced that the Company's wholly-owned subsidiary, Prometic Plasma Resources ( USA ) Inc., has received U.S. Food and Drug Administration approval for its plasma collection

• JUD care Obtains FDA Approval for Its Portable Ward sRoom

  1/12/2021

  JUD care, a leading high-tech enterprise in the field of smart medical and healthcare solutions, has obtained approval from the US Food and Drug Administration for the portable ward sRoom, a revolutionary solution for patient isolation that enables hospitals to quickly set up emergency isolation rooms.

• ClearMind Biomedical's Axonpen Neuroendoscope Receives 510K Clearance

  1/11/2021

  ClearMind Biomedical has received FDA clearance for its novel neuroendoscope, the Axonpen System, for illumination and visualization of intracranial tissue and fluids, and the controlled aspiration of tissue and/or fluid during surgery. Requiring only a narrow channel of 6.5mm through the skull for insertion into the br

• Quanterix Receives FDA Emergency Use Authorization for SARS-CoV-2 N Protein Antigen Test

  1/11/2021

  Antigen test available on Simoa HD-X Analyzer® intended for qualitative detection of the nucleocapsid protein (N protein) from SARS-CoV-2 in nasopharyngeal swab specimens Full suite of Research Use Only Assays Also Available for SARS-CoV-2 Acute and Long Hauler Surveillance and Profiling Studies