FDA

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.

Dawnzera is the first and only RNA-targeted prophylactic therapy to be approved for hereditary angioedema in adults and pediatric patients aged 12 years and older.

The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic fibrosis Phase IIb trial (NCT06998043) while European dosing continues.

Tomnya is the first new fibromyalgia therapy approved by the FDA in over 15 years.

Expanded approval of Wegovy was based on results from the Phase III ESSENCE trial (NCT04822181), which demonstrated significant improvements in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis compared to placebo at 72 weeks.

An examination of proactive preparedness and readiness review for future enrollment in the agency’s QMM program—now in the pilot stage as an effort to incentivize pharma manufacturers to achieve a more mature state of quality culture.

Papzimeos is the first-and-only approved therapy for adults with recurrent respiratory papillomatosis.

Brinsupri is a first-in-class DPP1 inhibitor that has been found to inhibit activation of neutrophil enzymes that drive chronic airway inflammation in non-cystic fibrosis bronchiectasis.

Accelerated approval was based on results from the Phase Ib Beamion-LUNG 1 trial (NCT04886804), which showed a 75% objective response rate in patients with unresectable or metastatic non-squamous non-small cell lung cancer treated with Hernexeos.

Modeyso is the first and only approved treatment for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one year and older.

Ajovy becomes the first-and-only calcitonin gene-related peptide agonist approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs.