FDA feedback enables CervoMed to proceed with proposed endpoints, patient enrichment strategy, and other key aspects of Phase 3 trial design to ...
Opus Genetics has completed a Type B Regenerative Medicine Advanced Therapy (RMAT) meeting with the US Food and Drug ...
On September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announced that the FDA approved ...
The affected products contains bacterial levels higher than what is allowed.
Richter and Hikma have received the green light from the Food and Drug Administration for their biosimilar denosumab products, Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), referencing Prolia ...
MUMBAI, India, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Lords Mark Industries Ltd., has received US FDA registration for its range of surgical consumables, orthopedic supports, and hygiene products — a ...
Bangkok Post on MSN
Herbal inhaler unsafe: FDA
The Food and Drug Administration (FDA) has issued a public warning after laboratory tests revealed microbial contamination in ...
The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...
Lords Mark Industries Ltd., has received US FDA registration for its range of surgical consumables, orthopedic supports, and hygiene products, a milestone that reinforces its manufacturing excellence ...
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