FDA

GSK's Blenrep gains FDA approval, offering new hope for multiple myeloma patients with improved survival rates and community access.

Sanofi's Tzield gains FDA's expedited review, promising rapid access to innovative treatment for type 1 diabetes and addressing significant medical needs.

FDA approves innovative treatments for lupus nephritis and cardiovascular risk in diabetes, enhancing chronic disease management options for patients.

Amgen and AstraZeneca’s Tezspire (tezepelumab-ekko) gains FDA approval as an add-on maintenance therapy for patients aged 12 and older with inadequately controlled chronic rhinosinusitis with nasal polyps.

Nine medications are on the initial list of program participants.

Regeneron's Libtayo gains FDA approval as the first immunotherapy for high-risk cutaneous squamous cell carcinoma, enhancing patient treatment options.

FDA approves Jascayd, the first new treatment for idiopathic pulmonary fibrosis in over a decade, significantly reducing mortality risk for patients.

Johnson & Johnson's Simponi gains FDA approval for treating pediatric ulcerative colitis, expanding options for young patients with this chronic condition.

Neurizon Therapeutics advances ALS treatment as FDA lifts clinical hold on NUZ-001, paving the way for Phase II and III trials.

Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell lung cancer patients.

Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, enhancing treatment options and survival rates.

Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing disputes and approvals.

FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug applications and submissions.

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

The FDA has expanded Johnson & Johnson’s Tremfya (guselkumab) approval to children six years and older weighing at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis, marking the first pediatric approval of an IL-23 inhibitor for these conditions.

FDA approves Eli Lilly’s Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after endocrine therapy.

The FDA has expanded the indication of Incyte’s Opzelura (ruxolitinib) cream to include children aged two to 11 years with mild to moderate atopic dermatitis, making it the first steroid-free topical treatment option for this age group.

R-DXd has previously shown promising clinical results in platinum-resistant ovarian, peritoneal, and fallopian tube cancers.

Eli Lilly's Orforglipron may become the first drug fast-tracked under the FDA's new program, promising quicker access for weight loss treatment.

The pause follows a patient death in the SYNRGY trial evaluating the novel therapy for STXBP1-related disorders, as the company prioritizes safety and transparency with the community.

The designation supports expedited development of SAR402663, Sanofi’s one-time gene therapy designed to reduce treatment burden and slow vision loss in patients with wet age-related macular degeneration.

Approval was based on data from the Phase IIb SunRISe-1 trial (NCT04640623), in which Inlexzo demonstrated an 82% complete response rate in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Wayrilz is the first Bruton’s tyrosine kinase inhibitor to be approved for adults with persistent or chronic immune thrombocytopenia who have not responded adequately to prior therapy.

FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.

New indication positions Repatha as an option for high-risk adults with elevated LDL cholesterol and no prior cardiovascular events.