U.S. FDA: Approves new breakthrough therapy for cystic fibrosis
Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic options
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SOPHIRIS BIO: Receives Positive Feedback from FDA Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design
Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.
JANSSEN: Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids
NEUREN: FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes
Neuren Pharmaceuticals (ASX: NEU) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren’s NNZ-2591 for the treatment of Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome.
GENENTECH: Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications
Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu)
DAIICHI SANKYO: [Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.
AMERICAN GENE TECHNOLOGIES: IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies
Progress Toward the Goal of Achieving a Functional Cure for HIV Disease
JANSSEN: Presents New Four-Year TREMFYA® (guselkumab) Data Demonstrating Maintained Rates of Skin Clearance in Adult Patients with Moderate to Severe Plaque Psoriasis
At 204 weeks, patients receiving TREMFYA® in a clinical study continue to show maintained PASI 90 and IGA 0/1 responses
AMGEN: Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
32% of Patients Achieved Treatment-Free Remission for at Least Six Months in a Single-Arm Trial
AMERICAN ASSOCIATION OF ORTHODONTISTS: California Passes Dental Law Regarding Self-Applied Orthodontic Treatments
On October 13, 2019, California Governor Gavin Newsom signed Assembly Bill 1519 into law, granting the California Dental Board continued authority to oversee and regulate dental services in the state.
FOAMIX: Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea
PDUFA Target Action Date of June 2nd, 2020
OMEGA MEDICAL IMAGING: First in the World to Receive FDA Clearance on Artificial Intelligence Imaging System That Reduces Dose
Omega Medical Imaging, manufacturers of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, just announced the Food and Drug Administration 510 (k) clearance of FluoroShield™ with their 2020 Cardiac Flat Panel Detector.
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Hackensack Meridian Health launches $1 million 'Take Vape Away' campaign
Hackensack Meridian Health has invested $1 million in a comprehensive strategy to curb the vaping epidemic through its "Take Vape Away" campaign.
FDA approves Eli Lilly migraine treatment Reyvow
Eli Lilly and Co.'s Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura in adults has received approval from the U.S. Food and Drug Administration (FDA).
DENOVO BIOPHARMA: Receives FDA's Permission to Proceed with a Biomarker-Guided Phase 2b Clinical Trial with DB102 (Enzastaurin) In First-Line Treatment of Glioblastoma (GBM)
pies, today announced FDA's approval to initiate Denovo's Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation an
JANSSEN: U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients
XARELTO® provides a new oral option to help prevent venous thromboembolism (VTE) and VTE-related death during hospitalization and post-hospital discharge in acutely ill medical patients at risk for VTE and not at high risk of bleeding
BOEHRINGER INGELHEIM: FDA Grants Ofev® Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
The designation was supported by results from the Phase III INBUILD® study that met its primary endpoint and was recently published in the New England Journal of Medicine
EICOSIS: Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain
EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate Phase 1 clinical trials for their drug candidate, EC5026, for the treatment of pain.
U.S. FDA: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens
The U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).
FIRSTKIND LTD: FDA Clears GEKO DEVICE for Use in Non-surgical Patients at Risk for Deep Vein Thrombosis Based on Study Demonstrating a Zero Percent DVT Rate in Patients After a Stroke
Sky Medical Technology furthers presence in 3.5bn1 dollar US market for VTE prevention