R&D/Clinical Trials

Study reportedly demonstrates the encouraging safety profile of satri-cel, the first autologous Claudin18.2 CAR T cell therapy.

Today's FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.

Analytics capabilities are no longer a nice-to-have, but a necessity to build and maintain a successful business and competitive edge.

Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.

Novocure’s tumor-treating fields plus standard-of-care therapies is under evaluation in patients with non-small cell lung cancer following disease progression on or after platinum-based treatment.

Pivmecillinam has already been approved in Europe to treat uncomplicated urinary tract infections.

NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.

Bloomlife’s MFM-Pro is a prescription-based wearable device that can track the maternal and fetal heart rate.

Fran Gregory, VP of Emerging Therapies, Cardinal Health discusses her career, how both CAR-T therapies and personalization have been gaining momentum and what kind of progress we expect to see from them, some of the biggest hurdles facing their section of the industry, the importance of patient advocacy and so much more.

HyQvia is the only subcutaneous immune globulin infusion that can be administered once per month.

Vertex Pharmaceuticals' and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease.

The data was collected during the LEAP clinical program, developed in partnership with Merck.

Company displayed findings at the 2024 Winter Clinical Dermatology Conference in Hawaii demonstrating significant improvements in atopic dermatitis and seborrheic dermatitis.

Dupixent is an IL-4 receptor alpha antagonist that has been approved for the treatment of adults with moderate-to-severe atopic dermatitis, as well as asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.

The FDA issued the 39th overall approval for Keytruda (pembrolizumab), with the latest in combination with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

RC88 is under evaluation for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Axon Therapy uses magnetic peripheral nerve stimulation to deliver a non-invasive treatment for chronic pain related to nerve damage caused by diabetes.

If the FDA approves the abbreviated new drug application for Lutetium Lu 177 Dotatate, the drug will be eligible for 180 days of generic marketing exclusivity in the United States for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors.

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia.

SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation.

Lutikizumab (ABT-981) will advance to a Phase III trial in patients with moderate to severe hidradenitis suppurativa who previously failed anti-tumor necrosis factor therapy.

Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

Scemblix (asciminib) plus investigators’ choice of tyrosine kinase inhibitor showed clinically meaningful and statistically significant data in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Merck is actively enrolling patients across Phase III trials for four novel candidates for hematologic malignancies and solid tumors.

Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.