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.
Progress Toward the Goal of Achieving a Functional Cure for HIV Disease
At 204 weeks, patients receiving TREMFYA® in a clinical study continue to show maintained PASI 90 and IGA 0/1 responses
32% of Patients Achieved Treatment-Free Remission for at Least Six Months in a Single-Arm Trial
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.
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.
PDUFA Target Action Date of June 2nd, 2020
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 has invested $1 million in a comprehensive strategy to curb the vaping epidemic through its "Take Vape Away" campaign.
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).
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
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
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).
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 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.
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).
Sky Medical Technology furthers presence in 3.5bn1 dollar US market for VTE prevention
HB Natural Ingredients has received a "Letter of No Objection" for Vitosa stevia sweeteners from the U.S. Food and Drug Administration (FDA), confirming that the agency has "no questions" on the self-affirmed GRAS (generally recognized as safe) status of Vitosa for use as a sweetener in food and beverage products.
The U.S. Food and Drug Administration (FDA) recently granted marketing approval to use Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
Octapharma USA announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.