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135 articles with FDA
NorthStar Medical Radioisotopes, LLC Announces Business Update and Commercial Progress on RadioGenix® System Launch
Positive RadioGenix System market momentum continues
Tivic Health Receives FDA 510(k) Clearance To Market ClearUP™ To Treat Sinus Pain Associated With Allergic Rhinitis/Hay Fever
Tivic Health Systems Inc. today announced that ClearUP Sinus Pain Relief, a first-in-class bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Aadi Bioscience Receives Breakthrough Therapy Designation for TARZIFYX™ (ABI-009) in PEComa Indication
Lead Registration study in Advanced Malignant PEComa completes enrollment and company is On-Track for 2019 NDA Filing
Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds
Today, the Agriculture Improvement Act of 2018 was signed into law.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales
When new safety concerns arise for particular devices, we're committed to taking action to develop post-market information that can help patients and providers make more informed decisions and also support regulatory actions that reduce any potential risks to patients.
Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes' Physician-Sponsored IDE
Device will be paired with Aortica Corp.’s AortaFit™ Automated Fenestration Alignment Software to Simplify Treatment of Complex AAA Disease / Provide Personalized Vascular Therapy
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework
Our public health obligations touch on many aspects of how medical products are developed and used by patients and providers.
Thermo Fisher Scientific Launches Complementary Diagnostic Immunoassay Measuring Plazomicin Concentrations
Thermo Fisher Scientific has received FDA clearance for its de novo submission of the Thermo Scientific QMS Plazomicin Immunoassay, the first of its kind for complementary diagnostic immunoassays.
Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
Earlier this week, the FDA announced new steps to modernize FDA's 510(k) clearance pathway, used for low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device.
Sciton, Inc. announced today that the FDA has advised the company that it appears that Sciton has satisfactorily addressed all items raised by the FDA in its July 24, 2018 "It Has Come to Our Attention" letter.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA's expanded access program
Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma
One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy.
Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
Over the past several months, we've continued to voice our concerns about the growing epidemic of youth e-cigarette use.
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency's approval of Dsuvia and the FDA's future consideration of new opioids
The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA.
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA's efforts to prevent future outbreaks
Earlier this year, we experienced the largest E. coli O157:H7 outbreak the country has seen in the last decade, leaving hundreds sick and claiming the lives of five people who consumed contaminated romaine lettuce.
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency's efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
With the number of overdose deaths from prescription and illicit opioids doubling from 21,089 in 2010 to 42,249 in 2016, it's critical that we continue to tackle this human tragedy from all fronts – including, and importantly, looking at new ways to increase the availability of naloxone.
Alphamab Oncology's HER2 bispecific antibody KN026 gained US IND approval; phase I clinical trial started in China
Alphamab Oncology announced that it has received US FDA's IND approval for its proprietary HER2 bispecific antibody (product code: KN026), and KN026 is anticipated to enter clinical development later in the US.
Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
This week marks the official start of "flu season" for 2018-2019. The FDA, along with its partners across the Department of Health and Human Services, has been working throughout the year to prepare the development of a safe, effective flu vaccine for the season.
HighTide Therapeutics Receives Fast Track Designation from the U.S. FDA for HTD1801 Treating Primary Sclerosing Cholangitis
HighTide Therapeutics Inc. announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with primary sclerosing cholangitis (PSC).