Neuroscience
New treatment shows promise against fatal neurological disease: Study
A new treatment shows promise against the deadly neurodegenerative disease ALS, a study based on mice showed Tuesday.
Jan 31, 2024
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News tagged with accelerated approval
Oncology & Cancer
Breakthrough drug approval signals great advances in lung cancer treatment
The International Association for the Study of Lung Cancer (IASLC) says the move by the U.S. Food and Drug Administration (FDA) to grant accelerated approval for a cutting-edge lung cancer treatment is a positive step forward ...
Oct 8, 2015
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Medications
Study results show conjugate therapy produced remissions in one-third of patients with drug-resistant ovarian cancer
In an internationally conducted clinical trial lead by Dana-Farber involving patients with recurrent ovarian cancer that is resistant to platinum therapy, a novel conjugate therapy called mirvetuximab soravtansine resulted ...
Jan 31, 2023
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Medications
FDA OKs Merck drug, first in new cancer drug class (Update)
Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments.
Sep 4, 2014
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Oncology & Cancer
FDA approves new therapy option for lung cancer patients who develop resistance to early generation EGFR inhibitors
The International Association for the Study of Lung Cancer (IASLC) commends the U.S. Food and Drug Administration's (FDA) decision to grant accelerated approval for osimertinib (Tagrisso), an oral medication for advanced ...
Nov 16, 2015
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Medications
Vijoice granted first approval for treatment of PROS
Vijoice (alpelisib) has been granted accelerated approval for severe PIK3CA-related overgrowth spectrum (PROS), the U.S. Food and Drug Administration announced April 6.
Apr 19, 2022
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Oncology & Cancer
FDA approves first CAR T-cell therapy for adults with leukemia or lymphoma
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed ...
Mar 19, 2024
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Oncology & Cancer
Trials supporting FDA approval of breakthrough drugs examined
(HealthDay)—Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups, according to a research letter published ...
Jul 18, 2018
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Medications
US makes new Alzheimer's drug more widely accessible
The US drug regulator gave full approval to a new Alzheimer's medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly.
Jul 7, 2023
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Medications
Medicare will cover new class of Alzheimer's drugs if fully approved by FDA, with limits
Medicare will soon cover a new class of Alzheimer's drugs if they receive full approval from the U.S. Food and Drug Administration, with some key limits.
Jun 2, 2023
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