UVision360 Inc., creators of the patented LUMINELLE® DTx Hysteroscopy System, announced the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE® Dx 360˚ Rotatable Disposable Sheath (Diagnostic).
Camurus AB (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request (through Citizen Petition) to revoke orphan drug designation of Sublocade™.
Innovative ventilation system that can be used across health care settings for full range of patients
The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.
All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").
A new partnership between CEFALY Technology and QB Medical puts wearable medical devices in the hands of health care providers and grants active military immediate relief from migraine headaches
Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020
Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).
Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets
LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market.
AASCP is hosting an FDA Panel and many distinguished physicians this weekend at their annual Scientific Congress. All physicians practicing stem cell treatments should not miss this event on Nov. 1-3, 2019.
The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
Over 60 New Tests of the Recalled Lot Conducted by Two Third-Party Laboratories Find No Asbestos
Med-botics, LLC Targets Post-operative Death and Harm from Opioids
To conduct in vitro testing of the effects of excipients on oral drug absorption
One of the U.S. Food and Drug Administration's top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for a number of reasons, shortages of certain medicines occur and the FDA works immediately with our public health partners and industry to minimize their impact on patients and restore the availability of these drugs.
Suntiva, a trusted advisor to leaders in achieving critical business transformation outcomes, is proud to announce that it recently won ten BPA orders with the U.S. Food and Drug Administration (FDA), with a total value of more than $9 million.
Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA requested VOYAGER top-line data to inform its review of fourth-line GIST indicatio
ARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).
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The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions.