Drug Approval | November 24, 2025
Lupin receives 7 observations from USFDA for Goa manufacturing facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The company will soon be launching a new portfolio of products in this segment
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
Millions of stroke survivors across the world may soon have a new defense
The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease
Paxton alleges the companies marketed Plavix as a reliable defense against heart attacks, strokes, and blood clots while failing to disclose evidence that the drug could be ineffective or virtually useless for many people
Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints
Desai is currently serving the company as Group Finance Controller
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