The archive
484 stories, newest first — page 2 of 21.
Conference Coverage
Alpha and beta emitters bring distinct dosimetry, manufacturing and safety challenges. A conference review highlights why their development cannot be judged as a cross-cancer efficacy contest.
Dr. Abu Bakar · 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
The FDA approved lirafugratinib for previously treated cholangiocarcinoma with an FGFR2 fusion or other rearrangement, adding a biomarker-defined option after earlier therapy.
Dr. Abu Bakar · 6 min read
Women's Health
The FDA approved imlunestrant plus abemaciclib for adults with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer after endocrine progression. ESR1 testing now determines eligibility.
Dr. Abu Bakar · 6 min read
Innovation & Devices
Updated Amplatzer Amulet instructions sort pulmonary artery injury risk into three distance bands for patients undergoing left atrial appendage closure.
Dr. Abu Bakar · 6 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
The FDA expanded Anktiva plus BCG to adults with BCG-unresponsive, high-grade papillary-only non–muscle-invasive bladder cancer, adding a bladder-preserving option for this underserved group.
Dr. Abu Bakar · 7 min read
Health Policy
An FDA Class I recall covers specified CooperSurgical INCA infant nasal CPAP set lots because tubing-to-cannula connections may loosen and interrupt respiratory support.
Dr. Abu Bakar · 6 min read
Infectious Disease
The Class I recall applies to Medline convenience kits containing affected BD ChloraPrep applicators. Facilities should quarantine listed inventory and assess patients with credible exposure and compatible illness.
Dr. Abu Bakar · 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
Endocrinology & Metabolism
The FDA boxed warning makes hypophosphatemia a central consideration when ferric carboxymaltose is selected, particularly for patients with risk factors or repeated exposure.
Dr. Abu Bakar · 6 min read
Innovation & Devices
Par Health recalled two lots of premixed dexmedetomidine after cellulose or stopper material was found. Critical care and procedural teams should quarantine affected inventory before use.
Dr. Abu Bakar · 6 min read
Innovation & Devices
The Class I correction applies to affected AVID Medical convenience kits containing Huons sodium chloride ampules. Facilities should quarantine stock, trace prior use and assess possible exposures.
Dr. Abu Bakar · 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