Search results
FDA posts final guidance on remanufacturing medical devices
MedTech Dive via Yahoo Finance· 5 days agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...
US FDA declines expanded use of Dynavax's hepatitis B vaccine on insufficient data
AOL· 15 hours ago(Reuters) -The U.S. drug regulator has declined to approve expanded use of Dynavax Technologies' hepatitis B vaccine in a section of patients, citing insufficient data over destruction of some ...
PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™
FOX 23 News Albany· 16 hours agoPTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the...
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 5 days agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
Baxter's (BAX) Clinolipid Gets FDA's Expanded Indication
Zacks· 23 hours agoFree Report) recently received the FDA’s approval for an expanded indication for Clinolipid (Lipid Injectable Emulsion) to be used in pediatric patients, including preterm ...
FDA extends review of Ascendis Pharma's hormone disorder therapy
Reuters via Yahoo Finance· 9 hours agoFood & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder, the company said on Tuesday. The FDA is now ...
Patients left without Adderall as national shortage continues
WCMH via Yahoo News· 5 hours agoCOLUMBUS, Ohio (WCMH) – It’s been more than a year since the FDA announced a national shortage of a...
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law | JD Supra
JD Supra· 21 hours agoThe landscape of laboratory testing in the United States is changing. On April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (FDA
FDA Declines To Approve Expanded Use of Dynavax's Hepatitis B Vaccine In Hemodialysis Patients -...
Benzinga· 14 hours agoThe FDA has issued a Complete Response Letter stating that the application did not provide sufficient data to fully evaluate the effectiveness or safety of a four-dose regimen ...
Orthofix Medical's (OFIX) Telescopic Nail Gets FDA Clearance
Zacks· 2 days agoOrthofix Medical (OFIX) announces the FDA clearance of its Rodeo Telescopic Nail, which is likely to...