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ASTELLAS PHARMA INC.: FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients

By Press release submission | Jan 8, 2021

FORGE BIOLOGICS: Announces FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Trial (RESKUE) of FBX-101 Gene Therapy for Patients with Krabbe Disease

By Press release submission | Jan 6, 2021

LYGENESIS: Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease, and also Closes $11 Million Convertible Debt Financing

By Press release submission | Dec 31, 2020

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GT BIOPHARMA: Announces FDA Data - Gtb-3550 Trike™ Reduces Cancer Cells by 61.7% for a High-risk Myelodysplastic Syndromes (HR-MDS) Patient

By Press release submission | Dec 21, 2020

GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE™) technology platform is pleased to announce the presentation of additional interim data results for the Company's lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS).

MOLECULIN: Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases

By Press release submission | Dec 17, 2020

Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) is allowing the company's Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect.

NEOIMMUNETECH: Receives U.S. FDA IND Clearance for Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer

By Press release submission | Nov 19, 2020

NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of its lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and atezolizumab (Tecentriq®) for the treatment of patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC).

NUVATION BIO: Announces FDA Acceptance of Investigational New Drug (IND) Application for NUV-422 for Treatment of Patients with High-grade Gliomas

By Press release submission | Oct 15, 2020

First compound from pipeline of six early-stage oncology programs to advance into clinical development-

NRX: NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19

By Press release submission | Oct 15, 2020

RLF-100™ therapy associated with a 9-fold increased probability of survival and recovery from respiratory failure in an open-label, prospective study

POLARYX THERAPEUTICS: Receives FDA Fast Track Designation to PLX-200 for the Treatment of Patients With Juvenile Neuronal Ceroid Lipofuscinosis

By Press release submission | Aug 23, 2020

Polaryx Therapeutics Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3) patients.

MALLINCKRODT: Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft® Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns

By Press release submission | Aug 13, 2020

StrataGraft® Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds

SIEMENS HEALTHINEERS AG: FDA Clears SOMATOM On.site from Siemens Healthineers For CT Head Exams at Patient’s Bedside

By Press release submission | Aug 9, 2020

Mobile CT scanner reimagines head imaging of critically ill patients by enabling patients and staff to remain in ICU

ABIOMED: FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

By Press release submission | Aug 4, 2020

The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.

CAN-FITE: Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study

By Press release submission | Jul 31, 2020

28-day study in hospitalized patients with moderate COVID-19 symptoms

STRATUS™ MEDICAL: Announces FDA 510k clearance for the Vesta™ RF Cannula to expand product portfolio and the first Vesta patient treatments in the United States

By Press release submission | Jul 30, 2020

Stratus™ Medical, a company focused on advancing radiofrequency (RF) ablation treatment for chronic pain, announced today FDA clearance for the Vesta RF Cannula for use in radiofrequency (RF) heat lesion procedures for the relief of pain and first Vesta patient treatments in the United States.

GSK: Announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma

By Press release submission | Jul 15, 2020

Recommendation based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study

COMPANION MEDICAL: InPen Receives FDA Clearance for Expanded Pediatric Use

By Press release submission | Jun 26, 2020

Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, announced that they received FDA expanded clearance for all ages* to use the InPen System.

CLEW: Receives FDA Emergency Use Authorization (EUA) for Its Predictive Analytics Platform in Support of COVID-19 Patients

By Press release submission | Jun 18, 2020

CLEWICU is the only device authorized by the FDA to provide early identification of patients who are likely to experience respiratory failure or hemodynamic instability, both potentially common but significant complications associated with COVID-19

FDA: Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products

By Press release submission | May 30, 2020

Agency Continues Investigations of Nitrosamine Impurities in Drug Products

THERANICA: Expands Executive Team Amid Growing US Demand for Its FDA-authorized Migraine Treatment Wearable Device

By Press release submission | May 19, 2020

During Initial Limited Commercial Launch, Nerivio® Was Used more than 30,000 Times to Address Migraine Pain and other Symptoms

AACC: Not All FDA-Authorized COVID-19 Antibody Tests Are Equally Reliable

By Press release submission | May 15, 2020

Crucial findings published in AACC's Clinical Chemistry journal

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