Myqorzo is an allosteric inhibitor of cardiac myosin, reducing hypercontractility in obstructive hypertrophic cardiomyopathy, improving heart function. The Phase 3 SEQUOIA-HCM trial showed significant ...
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The global pharmaceutical REMS market — a critical safety framework for high‑risk drugs — is on track to expand from approximately USD 1.73 billion in 2024 to about USD 6.12 billion by 2034, ...
NEW YORK (PIX11) — Whether or not hundreds of thousands of New York City public housing residents and guests are safe when they ride the elevators in the sprawling housing system is at the center of ...
It was only about a year ago that the biopharma industry hailed a decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine ...
In a surprising announcement, the U.S. Department of Education’s Office of Safe and Supportive Schools announced the closure of the Readiness and Emergency Management for Schools (REMS) Technical ...
The following products no longer have a REMS requirement: Abecma; Breyanzi; Carvykti; Kymriah; Tecartus; and Yescarta. The Food and Drug Administration (FDA) has removed the Risk Evaluation and ...
The FDA has eliminated Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, determining that the safety program is no ...
When CAR T-therapies first reached the market, they came with warnings and monitoring requirements to protect patients — for good reason. Engineering a patient’s own immune cells into targeted cancer ...
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. The FDA has removed the Risk Evaluation and ...
The FDA has officially eliminated clozapine's risk evaluation and mitigation strategy (REMS) program, with all REMS operations stopped as of June 13. The announcement comes several months after a ...
Soon to be the official tool for managing Python installations on Windows, the new Python Installation Manager picks up where the ‘py’ launcher left off. Python is a first-class citizen on Microsoft ...
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