Davy James

By 2050, study estimates that cancer incidence and mortality rates will nearly triple in low-Human Development Index countries, highlighting an urgent need for enhanced global cancer prevention, early detection, and treatment strategies to address growing disparities.

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, gains FDA approval to treat HER2-overexpressing breast cancer and gastric cancer.

FDA fast tracks Sun Pharma and Moebius Medical’s MM-II treatment for osteoarthritis knee pain, with Phase III clinical trials planned to expedite a potential approval.

The FDA previously granted priority review to a biologics license application for V116 as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

Compared with piperacillin/tazobactam, Exblifep (cefepime/enmetazobactam) showed noninferiority and superiority in a clinical cure and microbiological eradication of complicated urinary tract infections.

Epkinly (epcoritamab-bysp), a subcutaneously administered, T-cell engaging, bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma following two or more prior lines of therapy.

Xolair was approved last week to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with IgE-mediated food allergy.

Bayer's BAY 2927088 is under evaluation to treat unresectable or metastatic non-small cell lung cancer with tumors harboring activating HER2 mutations.

SKYTyphoid, a single-dose typhoid conjugate vaccine jointly developed by SK bioscience and the International Vaccine Institute, showed a positive immunogenicity and safety profile across age groups.

Trial data show Dupixent is the first and only novel biologic drug to significantly improve lung function and reduce severe acute exacerbations in adults with uncontrolled chronic obstructive pulmonary disease.

Immune-Onc Therapeutics’ IO-202 is currently being analyzed as a monotherapy and in combination for patients with relapsed/refractory acute myeloid leukemia with monocytic differentiation or chronic myelomonocytic leukemia.

Ocifisertib (CFI-400945) is a first-in-class, novel PLK4 inhibitor that has been found to regulate centriole duplication in patients with acute myeloid leukemia.

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

The Federal Trade Commission and the Department of Health and Human Services are seeking public input to evaluate how policymakers can address chronic drug shortages and promote a resilient supply chain.

There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.

Augtyro was previously approved in November 2023 to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.

Roche and Repare came to terms on a deal in June 2022 to develop and commercialize camonsertib, which included a $125 million upfront payment and could have reached up to $1.2 billion based on clinical, regulatory, commercial, and sales milestones.

BXCL701 combined with Keytruda (pembrolizumab) is being evaluated for patients with metastatic castration-resistant prostate cancer with small cell neuroendocrine and adenocarcinoma phenotypes.

In clinical trials, bepirovirsen was found to recognize the RNA used by hepatitis B virus to replicate in infected liver cells.

Eohilia, a corticosteroid developed specifically to treat eosinophilic esophagitis, is comprised of a novel formulation of budesonide taken twice daily for 12 weeks in patients 11 years of age and older.