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Although the number of clinical trials has quadrupled, the number of FDA approvals remains stable over a 10-year period, highlighting workforce challenges in clinical research.

This is the fifth indication for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo and AstraZeneca) approved by the FDA.

There are unique complexities when implementing bispecific antibodies, including site of care considerations, monitoring, and management of adverse events.

These FDA-approved therapies are used to treat lymphoma after 2 or more lines of therapy and represent significant advancements in the treatment of lymphoma.

FDA-approved BiTE therapies for relapsed/refractory multiple myeloma show promising response rates, offering off-the-shelf alternatives to CAR T therapy.

The Librexia program includes 3 concurrent clinical trials, investigating milvexian’s use for ischemic stroke, acute coronary syndrome, and atrial fibrillation

Precision medicine revolutionized NSCLC treatment, targeting specific mutations like KRAS G12C with therapies such as adagrasib to improve patient outcomes.

MDMA-assisted therapy and psilocybin currently lead the way with potential approvals by the FDA.

New indications include Staphylococcus aureus bloodstream (SAB) infections, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.

The results indicate the need for targeted policies so that biosimilar competition can increase cost savings and affordability for patients with commercial insurance.

This medication is associated with a number of adverse effects, such as gastrointestinal upset and peripheral neuropathies, that may be mitigated by less frequent dosing.

The decision follows phase 3 trial results that demonstrated improved progression-free survival and confirmed the safety of Dato-DXd in patients with breast cancer.

By implementing easier systems of education for patients, the consequences of polypharmacy could potentially decrease.

Positive phase 3 trial results showed that danicopan was more effective than placebo when treating extravascular hemolysis in paroxysmal nocturnal hemoglobinuria.

Scientists hypothesize that fecal microbiota transplant restores the recipient’s gut microbiota to an environment that mimics the healthy donor’s microbiota

However, investigators found that the prevalence of Streptococcus pneumoniae nasopharynx-oropharynx colonization was higher among younger adults.

Interactions between nirmatrelvir/ritonavir and direct oral anticoagulants is complicated, and a point of contrasting views between the US and EU medical communities.

Investigators identify 32 performance measures in the final set grouped into 10 categories of disease or health condition.

An overview of the use of direct oral anticoagulants as an alternative to warfarin in the treatment of left ventricular thrombus.

The recent ODD for the utidelone injectable could offer another treatment option for patients with BCBM.

The mutations, C594Y and P735R, were found in the GNE gene and may influence sialylation, a process that is crucial for brain development.

Pediatric patients with the variant were approximately 1.44 times more likely develop ALL compared with children who do not have the variant.

Investigators found that mRNA technology for the delivery of antibody therapeutics were used to target tau in Alzheimer disease and can be applied to other tau targets.

The ODD comes after AP303 presented meaningful improvements in renal survival in an ADPKD and the completion of the first study that evaluated healthy human participants.

As the full act will be enforced in November 2024, all medication dispensers must ensure they’re fully prepared.

The results displayed a dramatic reduction in the individuals’ tumors within days after single treatment.

Calder’s 3D Vaxlock technology attained 11 times more effective immune response, compared to typical comparator.

The authors believe that pancreatic enzyme therapy has potential in managing patient symptoms, altering the disease course, and the development of standardized care.

A study that analyzed data from 2000 to 2021 indicated improvements for both leukemia-free survival and overall survival for older patients with acute myeloid leukemia.

All 20 participants in a 12-month follow-up study attained acute success from ablation procedures.