Acute myeloid leukemia drugs
Jul 22, 2025
Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths; ImCheck’s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia; RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn’s Disease Approval Pathway; FDA Grants Fast Track Designation to ProMIS Neurosciences’ PMN310 for Alzheimer’s Disease; Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis
Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths Sarepta Therapeutics, Inc. has voluntarily and temporarily paused all shipments of ELEVIDYS (delandistrogene moxeparvovec) in the U.S., effective July 22, 2025, following engagement with the FDA on safety labeling u...
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Jun 03, 2025
Beam’s BEAM-302 Earns FDA Orphan Drug Tag for AATD; Incannex’s IHL-42X Moves to Phase III After FDA Protocol OK; Kura and Kyowa Kirin’s Ziftomenib Gets FDA Priority Review in NPM1-Mutant AML; GSK’s Linerixibat NDA Accepted by FDA for PBC-Linked Pruritus; Ascendis’ TransCon CNP Granted FDA Priority Review for Achondroplasia
Beam Therapeutics Secures FDA Orphan Drug Designation for BEAM-302 in AATD Beam Therapeutics Inc. announced that the FDA has granted Orphan Drug Designation to its investigational therapy, BEAM-302, for the treatment of alpha-1 antitrypsin deficiency (AATD). BEAM-302 is a liver-targeting lipid nanoparticle (LNP)...
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Feb 10, 2025
Acute Myeloid Leukemia: The Battle, The Breakthroughs, The Future
Acute Myeloid Leukemia (AML) is a rapidly progressing cancer that originates in the bone marrow—the soft, inner part of bones where blood cells are produced—and swiftly moves into the blood. Globally, the burden of AML has been increasing over the past few decades. The exact cause of AML remains elusive, but severa...
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Feb 07, 2025
10 Game-Changing Acute Myeloid Leukemia Drugs Revolutionizing Treatment
Acute Myeloid Leukemia (AML) is a fast-moving and aggressive cancer that demands timely and effective treatment. With the current acute myeloid leukemia therapies showing limited success for many patients, the focus has shifted to breakthrough AML drugs that are redefining the treatment landscape. From innovative s...
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