Johnson & Johnson announces that the U.S. FDA has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis in children weighing at least 15 kg. This approval provides a new subcutaneous treatment option for younger UC patients.
In a major breakthrough for oncology, the U.S. FDA has approved a new combination therapy from Roche for a highly aggressive form of lung cancer. The treatment, which combines Tecentriq® (atezolizumab) and lurbinectedin (Zepzelca®), is the first of its kind for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). Clinical trial results show the regimen significantly reduces the risk of disease progression and death, offering new hope and a pivotal shift in how this challenging disease is managed post-chemotherapy.
The U.S. Food and Drug Administration (FDA) has given approval to TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in children. This groundbreaking approval makes TREMFYA® the first and only IL-23 inhibitor available for pediatric patients, offering a new ray of hope for thousands of children affected by these chronic conditions.
AbbVie reaches a key milestone by submitting a Biologics License Application (BLA) to the FDA for Pivekimab sunirine (PVEK), an investigational Antibody-Drug Conjugate (ADC) designed to treat the rare and aggressive blood cancer, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).
The U.S. Food and Drug Administration (FDA) has officially approved Eli Lilly and Company’s Inluriyo (imlunestrant), a new oral therapy for adult patients with advanced or metastatic estrogen receptor-positive (ER+), HER2-negative breast cancer that has an ESR1 mutation. The approval is based on the pivotal Phase 3 EMBER-3 trial, which demonstrated that Inluriyo significantly reduced the risk of disease progression or death by 38% in this patient population, offering a new and convenient treatment option for a challenging form of breast cancer.
The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda Qlex, a new subcutaneous formulation of its leading cancer immunotherapy drug. This game-changing approval introduces a fixed-dose combination of pembrolizumab and berahyaluronidase alfa-pmph, allowing the treatment to be administered as a simple injection in as little as one minute, a significant reduction from the previous 30-minute intravenous infusion. Approved for most of Keytruda’s existing solid tumor indications in adults, this new formulation was shown in clinical trials to have a comparable efficacy and safety profile to the IV version. The approval marks a major advancement in patient-centered care, offering a more convenient and less time-consuming option for thousands of cancer patients.
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new subcutaneous (at-home) induction option for TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis. This approval, based on the successful Phase 3 ASTRO trial, makes TREMFYA the first and only IL-23 inhibitor to offer a completely subcutaneous regimen for both induction and maintenance, providing a significant new convenience for patients managing their condition.
U.S. Food and Drug Administration (FDA) has officially approved INLEXZO™ (gemcitabine intravesical system), a novel drug-delivery system from Johnson & Johnson set to revolutionize care for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This first-of-its-kind therapy offers a significant bladder-sparing alternative for a high-risk patient group often facing complete bladder removal. Clinical trials showed an 82% complete response rate, marking a major advancement in bladder cancer treatment.
Eli Lilly announced its novel cancer drug, olomorasib, has been granted Breakthrough Therapy designation by the U.S. FDA. This significant milestone aims to expedite the development of the treatment for patients with advanced KRAS G12C-mutated non-small cell lung cancer, a historically difficult-to-treat condition.
Pfizer and BioNTech’s updated COMIRNATY vaccine, targeting the LP.8.1 COVID-19 sublineage, gained FDA approval for use in seniors and high-risk individuals aged 5 to 64. The vaccine promises enhanced immune defense against current variants and is set for immediate distribution across the U.S.
