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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).

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.

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

FDA Update: September medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration (FDA).

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

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

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).

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.

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.

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.

FDA Update: September inspection citations

The U.S. Food and Drug Administration (FDA) inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

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

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.

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)

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.

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

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