Browsing Tag
US FDA
378 posts
Lupin receives US FDA nod for Nagpur injectable facility manufacturing drug-device combinations
Lupin secures US FDA EIR for its Nagpur injectables facility, boosting export potential and complex generics expansion. Read how this impacts global strategy.
Gland Pharma wins key FDA nod for $55m painkiller drug, but stock slips after initial surge
Gland Pharma secures US FDA approval for Acetaminophen Injection as its stock sees volatility. Find out what this means for investors and market strategy.
Senores Pharmaceuticals expands US footprint with Roflumilast ANDA acquisition
Senores Pharmaceuticals Limited has taken a significant step in its US expansion strategy by acquiring an Abbreviated New…
Lupin shocks the market with massive profit gains in Q3 FY2025—here’s what you need to know
Lupin Limited, a leading global pharmaceutical company, has reported strong financial results for the third quarter of fiscal…
FDA authorizes Virtual Incision’s MIRA: A leap forward in robotic-assisted surgery
Virtual Incision Corporation has achieved a groundbreaking milestone with the U.S. Food and Drug Administration (FDA) granting marketing…
FDA approves biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals
Alvotech and Teva Pharmaceuticals have achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval…
Orchid Pharma bags FDA approval for Enmetazobactam, first Indian-invented beta lactamase inhibitor
Chennai-based Orchid Pharma has achieved a significant milestone by receiving approval from the United States Food and Drug…
FDA approves first generic RECTIV ointment by Cosette Pharmaceuticals
In a landmark move for the pharmaceutical industry, Cosette Pharmaceuticals, Inc. has received approval from the U.S. Food…
Immune-Onc Therapeutics gets FDA orphan drug status for IO-202 in CMML
Immune-Onc Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapies in immunology and oncology,…
FDA approves Iovance’s AMTAGVI: A breakthrough in melanoma treatment
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a trailblazer in the field of biotechnology focused on developing novel polyclonal tumor…