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FDA launches Operation Stork Speed to enhance oversight for infant formula
This initiative builds on the agency’s January announcement to “enhance” oversight of infant-formula production as part of a ...
FDA, HHS announce plans to increase testing for heavy metals, contaminates in baby formula
The FDA and HHS announced "Operation Stork Speed" Tuesday, which aims to increase testing for heavy metals and other ...
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How consultants help accelerate drug product development timelines
Pharmaceutical consultants apply their comprehensive expertise in different areas to accelerate the drug development process.
BioInvent International: BioInvent Receives FDA Orphan Drug Designation for BI-1808 for the Treatment of T-cell Lymphoma
LUND, SE / ACCESS Newswire / March 20, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class i ...
Business Insider10d
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
About FDA Fast Track Designation At this stage of development, a drug that receives Fast Track designation is eligible for some or all of the following: More frequent meetings with FDA to discuss the ...
The Manila Times22h
XORTX Announces Update for Discussion with the FDA
The Company will provide further updates following communications with the FDA when additional information is available.
Acute Myeloid Leukemia Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
In March 2025, Akeso initiated an open-label, Phase Ib/II study involving patients diagnosed with acute myeloid leukemia (AML ...
CBS News1d
FDA to increase testing for heavy metals in infant formula, RFK Jr. says
The U.S. Food and Drug Administration will step up ... to promote health and wellbeing during critical stages of development and life," Acting FDA Commissioner Sara Brenner said in a statement.
The Manila Times2d
Nurix Announces U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia
Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström ...
Protagonist Therapeutics Named to Fast Company’s Annual List of the World’s Most Innovative Companies of 2025
Fast Company's annual list of the World's Most Innovative Companies spotlights organizations across various industries that are driving meaningful change through groundbreaking ideas and ...