FDA notifies Amgen of misbranding of its biological product Neulasta
Jul 14, 2021 · Amgen Inc. released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta when administered through the …
FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY ... - Amgen
THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ …
FDA APPROVES LUMAKRAS® (SOTORASIB) IN COMBINATION …
Jan 17, 2025 · The FDA completed its review of Amgen 's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023, which resulted in a …
Study of Amgen’s early obesity candidate paused by FDA
1 day ago · Amgen has so far said little about the drug, dubbed AMG 513, and has not described the drug’s mechanism. On a call with analysts, Amgen executives did not explain why AMG …
FDA grants accelerated approval to tarlatamab-dlle for lung cancer
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease...
Amgen's early-stage obesity asset slapped with FDA hold
1 day ago · Amgen’s mysterious obesity asset will remain a mystery for a bit longer—the FDA has put the candidate’s phase 1 trial on a clinical hold, the company announced Feb. 4. Amgen …
AMGEN PROVIDES REGULATORY UPDATE ON STATUS OF …
THOUSAND OAKS, Calif., Dec. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the …
US FDA panel says Amgen lung cancer drug data cannot be …
Oct 5, 2023 · An FDA spokesperson said the agency cannot comment on its next steps but it intends to keep the drug available for patients for now.
FDA approves Amgen's interchangeable biosimilar of J&J's Stelara
Nov 1, 2023 · Amgen’s biosimilar approval has an added advantage as it has captured an interchangeable designation, which allows a pharmacist to freely substitute it for Stelara, …
Amgen's request for full approval of Lumakras denied by FDA
Dec 27, 2023 · Amgen will have until February 2028 to complete a new study confirming the clinical benefit of Lumakras. The biopharma also announced Tuesday that the FDA has …
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