SEQSTER: Streamlines Regulatory Submissions & Health Data Sharing with FDA 21 CFR Part 11 Compliance
Patient-Centric Engagement Platform Passes High-Level Compliance Greatly Benefiting Pharmaceutical Enterprises
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FDA: Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19
As part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their
ABBVIE: Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis
RINVOQ demonstrated significant improvements to signs and symptoms of active ankylosing spondylitis[
KAZIA THERAPEUTICS LTD: US FDA Awards Orphan Drug Designation (ODD) To Paxalisib For Malignant Glioma, Including DIPG
Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.
AMIDEBIO, LLC: U.S. FDA grants rare pediatric disease designation to AmideBio's glucagon analog for the treatment of congenital hyperinsulinism
AmideBio, LLC, a privately held biopharmaceutical company, announced that the US Food and Drug Administration (FDA) Offices of Pediatric Therapeutics and Orphan Products Development granted a rare pediatric disease designation to AmideBio's glucagon analog (AB-G023) for the treatment of congenital hyperinsulinism (CHI).
UNITED THERAPEUTICS: Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Tyvaso® For Pulmonary Hypertension Associated With Interstitial Lung Disease
United Therapeutics Corporation (Nasdaq: UTHR) announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
FDA: Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
Agency Also Announces Qualification of a Medical Device Development Tool to Aid in the Effectiveness Assessment of Devices Used in Breast Reconstruction
BAXTER: Obtains U.S. FDA Emergency Use Authorizations for HF20 Set and ST Set Used in CRRT During Covid-19 Pandemic
Provides additional options to help meet increased demand for continuous renal replacement therapy (CRRT) products resulting from COVID-19 pandemic
AKESO, INC.: ANTI-PD-1/CTLA-4 Bi-specific Antibody (AK104) of Akeso Granted FDA Fast Track Designation for Recurrent and Metastatic Cervical Cancer
The Fast Track Designation of AK104 is another significant milestone in the development of this innovative bispecific antibody.
NEUROX INC.: FDA Grants Inhaled Use IND for RLF-100 (Aviptadil) to Treat Patients With Moderate and Severe COVID-19 Aiming to Prevent Progression to Respiratory Failure
Aviptadil is now shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung
REVIRAL: Announces FDA Fast Track Designation Granted to Sisunatovir For The Treatment of Serious Respiratory Syncytial Virus Infection
ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection.
FDA: Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water
The EPA-approved protocol can be used to evaluate the effectiveness of treatments in reducing microbial contamination in agricultural water
FDA: Warns Companies Illegally Selling Hangover Remedies
U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC.
CHECKMATE PHARMACEUTICALS: Granted FDA Fast Track Designation for CMP-001 Combined with PD-1 Blockade in the Treatment of Certain Types of Metastatic or Unresectable Melanoma
Checkmate Pharmaceuticals, Inc. (Checkmate), a clinical-stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its product candidate, CMP-001
ZEBRA MEDICAL VISION: Secures its First FDA Clearance in Oncology, Boosting Early Detection of Breast Cancer in Mammograms
This latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt. In initial testing Zebra-Med conducted, a number of cases which were originally missed were alerted by Zebra Medical’s ‘HealthMammo’ algorithm and the patients were recalled and confirmed
VITA THERAPEUTICS: Receives Orphan Drug Designation from FDA for new novel treatment
Vita Therapeutics, Inc. announced that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne's Muscular Dystrophy (DMD).
FDA: Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
Authorization is also second to allow testing of pooled samples