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Amgen, Bkemv
US FDA approves Amgen's biosimilar to AstraZeneca's rare blood disorder treatment
The U.S. Food and Drug Administration approved on Tuesday Amgen's Bkemv, the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris.
Amgen Wins FDA Approval for First Biosimilar to AstraZeneca’s Soliris
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch
Amgen has made waves in the biosimilar field in recent years with its U.S.-first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. | Amgen has made waves in the biosimilar field in recent years with its U.
US FDA approves Amgen drug for small cell lung cancer
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung cancer that has worsened despite chemotherapy.
FDA approves Amgen drug for tough-to-treat form of lung cancer
Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.
Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris
The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to
Amgen's Rare-Disease Treatment Biosimilar Bkemv Gets FDA Approval
By Ben Glickman Pharmaceutical regulators approved Amgen's Bkemv, a biosimilar to rare-disease treatment Soliris. The Food and Drug Administration
USFDA gives nod to first interchangeable biosimilar for two rare diseases
Interestingly, Bkemv is the 53rd approved biosimilar in the U.S. The FDA has approved 13 of these as interchangeable biosimilars.
FDA approves interchangeable biosimilar to Soliris
The FDA has approved Bkemv as the first interchangeable biosimilar to Soliris to treat certain rare diseases. Bkemv is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria and for those with atypical hemolytic uremic syndrome,
15d
on MSN
Amgen Drug Wins US Approval for Advanced Small Cell Lung Cancer
Amgen Inc. won US approval for a new drug to treat a particularly aggressive form of advanced lung cancer, providing a badly ...
MedCity News
14d
Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval
Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen ...
14h
Should you buy Amgen’s stock above $300?
Amgen Inc. (NASDAQ:AMGN) has recently been in the news due to its involvement in the promising obesity drug market. Analysts ...
14d
on MSN
FDA approves new drug for deadly lung cancer
The U.S. Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung ...
11d
US FDA approves two biosimilars for blockbuster eye drug Eylea
The U.S. Food and Drug Administration on Monday approved Biocon unit's biosimilar to Regeneron Pharmaceuticals' blockbuster ...
16h
on MSN
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for ...
West Hawaii Today
10d
FDA approves drug for persistently deadly form of lung cancer
The Food and Drug Administration last week approved an innovative new treatment for patients with a form of lung cancer. It ...
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