Cytokinetics recently announced that MYQORZO (aficamten), a cardiac myosin inhibitor for adults with symptomatic obstructive hypertrophic cardiomyopathy, is now commercially available in the U.S. via ...

(RTTNews) - Organon (OGN) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON (etonogestrel implant). NEXPLANON is ...

In recent days, Grabar Law Office initiated an investigation into whether Cytokinetics’ officers and directors breached fiduciary duties by allegedly making materially false and misleading statements ...

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 ...

Risk evaluation and mitigation strategy (REMS) programs help ensure that the benefits of certain high-risk medications outweigh their risks. With the routine use of REMS programs, however, concerns ...

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 ...

The update now reduces the frequency of liver function monitoring to every 3 months from the onset of treatment. The Food and Drug Administration (FDA) has updated the risk evaluation and mitigation ...

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 ...