Don Tracy, Associate Editor

John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.

Approval marks the first generic version of liraglutide injection, referencing Victoza, for improving glycemic control in adults and children aged 10 years and older with type 2 diabetes, alongside diet and exercise.

Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a notable placebo-adjusted triglyceride reduction at 12 months.

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.

Amid the end of a national GLP-1 shortage, the FDA will now require all compounding, distributing, or dispensing of compounded tirzepatide injections to end within 90 days.

Collaboration aims to enhance PSMA-B ligand, a novel theranostic molecule in development for the treatment of prostate cancer.

Breakthrough Therapy designation for Trodelvy was granted based on promising results from the Phase II TROPiCS-03 study, which showed encouraging antitumor activity in both platinum-resistant and platinum-sensitive extensive-stage small cell lung cancer.

Approval of Steqeyma was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis.

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.

How alternative direct-to-consumer models are changing the landscape for patient access.

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.

Berger joins Gilead with over 25 years of global drug development experience and will oversee the company’s virology, oncology, and inflammation portfolio.

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.

Mohamed Haitham Ayad, CEO, co-founder, SPIMA Therapeutics, discusses the company’s launch and how multiple institutions have supported its pipeline.

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.

Results from the SURMOUNT-5 Phase IIIb trial found that Zepbound achieved an average weight loss of 20.2%, surpassing Wegovy’s 13.7%.

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.

Licensing deals are expected to enhance the oncology, neuroscience, and antibody drug conjugate pipelines of the three manufacturers.

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.

Under terms of the deal, Roche will gain access to Poseida’s pipeline, including P-BCMA-ALLO1, an allogeneic CAR T-cell therapy for multiple myeloma, and P-CD19CD20-ALLO1, a dual CAR T-cell therapy in early trials for B-cell malignancies and autoimmune diseases.

Agreement grants Sarepta exclusive rights to several clinical-stage programs for muscular dystrophy, myotonic dystrophy type 1, and more.

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