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FDA accepts Sanofi’s Sarclisa sBLA for priority review
Pharmaceutical Technology via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has accepted for priority review Sanofi's supplemental...
Nearly 1.9 million Fiji water bottles sold through Amazon recalled over bacteria, manganese
USA TODAY via Yahoo News· 6 hours agoIn an enforcement report, the U.S. Food and Drug Administration said that testing by Fiji Water maker Natural Waters of Viti ...addition to three bacterial ...
FDA says to return, toss Texas brand of baby formula
San Antonio Express-News· 2 days agoThe U.S. Food and Drug Administration (FDA) has recalled a Texas brand of baby formula over the weekend and is urging parents to return ...
FDA Approves Elanco's Methane-Reducing Cattle Feed Additive By Investing.com
Investing.com· 1 day agoElanco Animal Health Incorporated (NYSE:ELAN) has received approval from the U.S. Food and Drug ...
Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests | JD...
JD Supra· 2 days agoThe U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years,...
Pfizer Stock Is Near An 11-Year Low — But Is It A Buy On This 'Massive' Upside?
Investor's Business Daily· 11 hours agoPfizer Stock And Recent News Pfizer recently won FDA approval for Beqvez, its gene therapy for...
Immunocore advances melanoma trial to phase 3 after FDA talks By Investing.com
Investing.com· 13 hours agoThis decision comes after recent consultations with the U.S. Food and Drug Administration (FDA) and...
FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
WJET - WFXP Erie· 1 day agoToday, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain ...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 2 days agoThe U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four ...
FDA Roundup: May 28, 2024
Clearfield Progress· 2 days agoOnly animal drug sponsors with Designated MUMS animal drugs or their research partners are eligible to apply. On Friday, the FDA the FDA
