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U.S. FDA ACKNOWLEDGES ASTELLAS' RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND...
The Pilot News· 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 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...
Small Business - The Andalusia Star-News | The Andalusia Star-News
The Andalusia Star-News· 6 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· 21 hours agoThe U.S. Food and Drug Administration(FDA) said on Thursday it plans to restructure its food...
Nationwide water recall update as FDA issues level of concern
Newsweek· 4 days agoThe U.S. Food and Drug Administration (FDA) has issued an update regarding a previous recall for...
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...
FDA’s Final Rule on IVDs: a stop gap en route to the VALID Act?
Medical Device Network via Yahoo Finance· 2 days agoAfter years of back and forth with industry, the FDA has made explicit that IVDs are medical devices...
FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
Pharmaceutical Technology via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has approved Teva Pharmaceuticals’ AUSTEDO XR...
URMC cosmetics director speaks on FDA warning for harmful counterfeit Botox
13WHAM Rochester· 20 hours agoThe FDA is warning about counterfeit Botox found in nearly two dozen states, including New York....
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