
Oncology
Anktiva Expands for Papillary-Only Bladder Cancer
The FDA expanded Anktiva plus BCG to adults with BCG-unresponsive, high-grade papillary non-muscle-invasive bladder cancer without carcinoma in situ.
Rayan Salih · 6 min read

Contributing writer · PharmD, RPh
Rayan is a pharmacist, life science communicator, and health policy researcher with a deep interest in ensuring patient access to innovative and life-changing therapies. She obtained her PharmD at Rosalind Franklin…
Rayan is a pharmacist, life science communicator, and health policy researcher with a deep interest in ensuring patient access to innovative and life-changing therapies. She obtained her PharmD at Rosalind Franklin College of Pharmacy and completed a postdoctoral fellowship focused on Health Policy & Communications at the National Pharmaceutical Council (NPC) in conjunction with Rutgers University. During her time at NPC, Rayan published HEOR-relevant research (e.g., on the Inflation Reduction Act, patient-focused drug development, and oncology access) in peer-reviewed journals like Pharmacoeconomics Open and Therapeutic Innovation & Regulatory Science. Rayan also supported the research team’s health policy and economic research projects, including abstract and poster development for conferences like AMCP, ISPOR, and ASCO. For the Rutgers portion of the fellowship, Rayan was an adjunct faculty member and led research projects in business development and health policy topics like alternative payment models (APMs) and the 340B program. Rayan continues to work at the intersection of innovative pharmaceutical advancement and communications as Chief Medical Writer at TheBrief.Health.
PharmD, RPh

Oncology
The FDA expanded Anktiva plus BCG to adults with BCG-unresponsive, high-grade papillary non-muscle-invasive bladder cancer without carcinoma in situ.
Rayan Salih · 6 min read

Innovation & Devices
The FDA recall affects specified Becton Dickinson intraosseous needle sets. Hospitals and emergency services should identify recalled stock while maintaining dependable alternatives for urgent vascular access.
Rayan Salih · 6 min read

Cardiology
Cardiac procedural teams should reconcile every automated Impella controller against the FDA-listed removal, including units in use, storage, transport kits and biomedical engineering custody.
Rayan Salih · 7 min read

Oncology
The FDA approved adjuvant atezolizumab plus chemotherapy after resection of stage III dMMR colon cancer in adults and patients aged 12 years or older. The subcutaneous formulation is limited to adults.
Rayan Salih · 6 min read

Oncology
The FDA action covers adults and children with unresectable or metastatic solid tumors measuring at least 13 mutations/Mb after prior progression when satisfactory alternatives are unavailable.
Rayan Salih · 7 min read

Oncology
The FDA has expanded talazoparib plus enzalutamide to selected adults with HRR-mutated metastatic castration-sensitive prostate cancer. Treatment requires mutation confirmation with an FDA-authorized test.
Rayan Salih · 7 min read

Endocrinology & Metabolism
The FDA has approved finerenone for renal protection in adults with type 1 diabetes and chronic kidney disease, using albuminuria reduction as the basis for the new pathway.
Rayan Salih · 6 min read

Oncology
The indication covers adults with stage II or III locally advanced rectal cancer that is MSI-H or dMMR, as established with an FDA-authorized test.
Rayan Salih · 6 min read

Women's Health
The FDA indication ties imlunestrant plus abemaciclib to an ESR1-positive result after endocrine therapy progression in ER-positive, HER2-negative advanced breast cancer.
Rayan Salih · 6 min read

Endocrinology & Metabolism
The FDA has elevated the hypophosphatemia warning for ferric carboxymaltose, affecting iron selection, patient counseling and phosphate evaluation.
Rayan Salih · 6 min read

Cardiology
An FDA early alert concerns an Edwards transcatheter mitral-valve delivery system, but key scope and response details remain unavailable to structural-heart teams.
Rayan Salih · 6 min read

Cardiology
The multicenter BASE trial will test cardiovascular and metabolic effects of beta-blocker therapy in people with aortic stenosis. Its protocol does not yet provide treatment-effect estimates.
Rayan Salih · 6 min read

Endocrinology & Metabolism
FDA approval of insulin efsitora alfa-gobe creates a weekly basal insulin option for adults with type 2 diabetes, making treatment burden, hypoglycemia risk and follow-up capacity central to selection.
Rayan Salih · 7 min read

Health Policy
The FDA authorized dostarlimab for eligible adults with stage II or III locally advanced rectal cancer, based on a 154-patient efficacy assessment. Confirmation of long-term clinical benefit is still required.
Rayan Salih · 7 min read

Neurology
The FDA-labeled population for FAYUVI is pediatric patients with MPS IIIA and preserved neurodevelopmental function, making timely developmental assessment central to treatment selection.
Rayan Salih · 6 min read

Oncology
Accelerated approval adds dostarlimab as an initial option for selected patients with untreated stage II or III MSI-H or dMMR rectal cancer, making organ preservation an early multidisciplinary decision.
Rayan Salih · 6 min read

Clinical Briefs
Traditional approval retains a narrow, tissue-agnostic indication for adults and children with previously treated, unresectable or metastatic TMB-high solid tumors and no satisfactory alternatives.
Rayan Salih · 6 min read

Oncology
The FDA has moved pirtobrutinib into previously untreated CLL and SLL, expanding first-line choice when therapy is indicated rather than reserving the drug for later lines.
Rayan Salih · 6 min read

Oncology
Accelerated approval makes dostarlimab an initial option for previously untreated stage II or III MSI-H/dMMR rectal cancer, with the possibility of avoiding chemotherapy, radiation and surgery.
Rayan Salih · 6 min read

Oncology
FDA traditional approval defines TMB-high solid tumors as at least 13 mutations per megabase. Eligibility depends on confirming that the reported result meets the new cutoff.
Rayan Salih · 7 min read

Oncology
In a phase 3 head-to-head trial, [177Lu]Lu-edotreotide extended progression-free survival compared with everolimus in progressive, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
Rayan Salih · 6 min read

Women's Health
The FDA approval applies to adults with ER-positive, HER2-negative advanced or metastatic breast cancer harboring an ESR1 mutation after endocrine-therapy progression. Guardant360 CDx is the companion diagnostic.
Rayan Salih · 7 min read

Oncology
The FDA’s accelerated approval covers previously treated adults with advanced nonsquamous NSCLC harboring activating HER2 tyrosine-kinase-domain mutations detected by an approved test.
Rayan Salih · 6 min read

Oncology
FDA accelerated approval covers selected previously untreated adults with MSI-H or dMMR locally advanced rectal cancer, allowing standard chemoradiation and surgery to be deferred when a complete clinical response is sustained.
Rayan Salih · 7 min read

Clinical Briefs
A Class I recall covers convenience kits containing potentially nonsterile 0.9% sodium chloride flush ampules. Affected ampules should be removed and discarded to prevent intravenous exposure.
Rayan Salih · 6 min read

Oncology
The FDA approval applies to adults with untreated stage II or III locally advanced rectal cancer whose tumors are MSI-H or dMMR. Testing must occur before the initial treatment strategy is fixed.
Rayan Salih · 6 min read

Oncology
The FDA approved atezolizumab plus fluoropyrimidine- and oxaliplatin-based chemotherapy after surgery for stage III mismatch-repair-deficient colon cancer.
Rayan Salih · 7 min read

Women's Health
The FDA-approved imlunestrant–abemaciclib combination applies to adults with ESR1-mutated, ER-positive, HER2-negative advanced breast cancer after endocrine progression.
Rayan Salih · 7 min read
Cardiology
In AMUNDSEN, evolocumab started before PCI rapidly lowered LDL cholesterol after acute myocardial infarction but did not improve clinical outcomes at 1 year.
Rayan Salih · 7 min read
Oncology
The FDA approved adjuvant atezolizumab plus chemotherapy for adults and patients aged 12 years or older with resected stage III mismatch-repair-deficient colon cancer.
Rayan Salih · 6 min read