Regulatory

New biologics license applications seek FDA approval for Merck’s clesrovimab to protect infants and children from respiratory syncytial virus and Johnson & Johnson’s Simponi for the treatment of ulcerative colitis.

Approval of Vtama for atopic dermatitis provides a steroid-free treatment option for adults and pediatric patients.

The Breakthrough Therapy Designation for Jemperli was based on Phase II clinical trial data, showing a 100% clinical complete response rate in patients with locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.

With the Inflation Reduction Act now in flux, how will the government and industry respond?

Approval of Unloxcyt was based on results from the CK-301-101 trial, which showed the drug is the first FDA-approved PD-L1–blocking antibody to produce clinically meaningful and durable objective response rates in patients with metastatic or locally advanced cutaneous squamous cell carcinoma.

The importance of expanding your pharma sales forecasting horizon beyond the US. Learn how to effectively navigate country-specific regulatory red flags.

The regulatory action was supported by results from the Phase III HERCULES trial, which demonstrated a 31% reduction in six-month confirmed disability progression in non-relapsing secondary progressive multiple sclerosis.

Real-world evidence from the largest analysis of second-line treatment with Yescarta in 2022-2023 demonstrated a high overall survival rate in patients with relapsed/refractory large b-cell lymphoma.

Breakthrough designation was based on results from the TROPION-Lung05 Phase II trial with support from the TROPION-Lung01 Phase III trial of datopotamab deruxtecan in patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

Ziihera’s addition as a category 2A treatment follows the FDA’s accelerated approval of the drug for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer.

The FDA based the Priority Review designation on results from the Phase III NIAGARA trial, which found that Imfinzi reduced the risk of disease progression, recurrence, or death by 32% in patients with muscle-invasive bladder cancer.

Acceptance of the application was based on results from the Phase III STARGLO study, which found that Columvi demonstrated a statistically significant and clinically meaningful overall survival improvement in patients with relapsed or refractory diffuse large B-cell lymphoma.

Approval of Imfinzi was based on results from the ADRIATIC Phase III trial, marking the first systemic immunotherapy available for limited-stage small cell lung cancer.

The breakthrough designation is based on Phase II clinical trial data, which demonstrated that ATX101 provides sustained pain relief for up to four weeks following total knee arthroplasty.

The breakthrough designation is based on data from the expansion cohort of a Phase I/II study evaluating sacituzumab tirumotecan in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

Acceptance of the Biologics License Application of Blenrep was based on promising results from the DREAMM-7 and DREAMM-8 Phase III trials in patients with relapsed or refractory multiple myeloma.

Approval was based on the combined results from five studies of adults with supraventricular tachycardia.

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.

Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer, addressing a critical unmet need with promising efficacy and improved quality of life.

The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.

Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino acid decarboxylase deficiency.

Pharma looks to take advantage of expanded access programs across Asia-Pacific region.

Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a previously withdrawn application to the FDA for nonsquamous non-small cell lung cancer.

Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.

Submissions to the FDA and EMA for new indication of Darzalex Faspro are based on results of the Phase III Aquila trial in patients with high-risk smoldering multiple myeloma.

The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal atrial fibrillation.

The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or mild dementia associated with Alzheimer disease based on data from the Clarity AD study.

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix's superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.