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FDA clears InnoVoyce’s VYLO Laser System for medical use
Medical Device Network via Yahoo Finance· 7 hours agoMedical technology company InnoVoyce’s VYLO Laser System has received 510(k) clearance from the US...
US FDA staff flags concerns on MDMA-assisted PTSD treatment
Reuters· 3 hours agoThe U.S. health regulator's staff reviewers on Friday raised concerns related to interpretation of...
U.S. FDA set to reorganize its food division starting October
Reuters via Yahoo News· 22 hours agoThe regulatory body had come under fire over its slow response to the infant formula shortage in...
FDA sets review date for Merck's KEYTRUDA in mesothelioma treatment By Investing.com
Investing.com· 2 days agoMerck & Co., Inc., a global healthcare leader, has announced that the U.S. Food and Drug...
U.S. FDA ACKNOWLEDGES ASTELLAS' RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND...
The Sun Chronicle· 13 hours ago(TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the ...
FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men
San Jose Mercury News· 22 hours agoAdvocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular,...
Small Business - The Andalusia Star-News | The Andalusia Star-News
The Andalusia Star-News· 7 hours agoFollowing the FDA, EMA also Grants an Orphan Drug Designation of SN Bioscience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer. SEOUL, South Korea, May 31, 2024 ...
U.S. FDA set to reorganize its food division starting October
Reuters· 22 hours agoThe U.S. Food and Drug Administration(FDA) said on Thursday it plans to restructure its food...
FDA rolls out platform technology guidance to smooth future regulatory encounters
FierceBiotech· 1 day agoTo speed up drug applications, the FDA has laid out new guidance on how to request a platform...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 1 day agoThe trade group wants the FDA’s final rule vacated, according to a lawsuit filed in the U.S. District Court for the Eastern District of Texas. The FDA...