Final results from the Phase IV PEARL trial show that 66% of patients treated with Ajovy for episodic migraine and more than half of those treated for chronic migraine who responded during the first six months maintained a ≥50% reduction in monthly migraine days.
Under terms of the deal, Kymera will lead early research on novel oral CDK2 degraders for solid tumors, with Gilead assuming responsibility for global development and commercialization if it exercises its option.
Results from the Phase III SUNMO trial show that the Lunsumio and Polivy combination achieved statistically significant improvements in both progression-free survival and objective response rate in patients with relapsed or refractory large B-cell lymphoma.
Pedro Valencia, VP, asset strategy leadership, oncology, AbbVie, explains how the company is advancing Temab-A across multiple tumor types targeting c-Met, with the goal of establishing it as a pipeline-in-a-molecule.
Early results from the Phase I/II NXTAGE trial show that NXT007 may achieve hemostatic normalization in patients with hemophilia A without factor VIII inhibitors.
Approval was based on results from the Phase II TROPION-Lung05 trial, which showed that Datroway demonstrated a strong overall response rate and duration of response in patients with previously treated, locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
Pedro Valencia, VP, asset strategy leadership, oncology, outlines how unmet need, treatment stagnation, and pipeline innovation shape the company’s approach to solid tumor oncology following key data presented at ASCO 2025.
Results from the Phase III QWINT-1, QWINT-3, and QWINT-4 trials show that once-weekly insulin efsitora alfa achieved A1C reductions up to 1.31%, demonstrating non-inferiority to daily basal insulin in patients with type 2 diabetes.
Results from the Phase III REDEFINE 1 trial show that CagriSema led to a 22.7% mean weight reduction at 68 weeks in adults with overweight or obesity and a weight-related medical condition, but without diabetes.
The Acuvue Oasys Max 1-Day Multifocal marks the first and only daily disposable contact lens to be available for people with both astigmatism and presbyopia.
Approval was based on results from the Phase III inMIND trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in patients treated with Monjuvi combined with rituximab and lenalidomide for relapsed or refractory follicular lymphoma.
The decision to advance prasinezumab to Phase III was based on results from the Phase IIb PADOVA trial, which demonstrated favorable trends towards slowed motor decline in patients with early-stage Parkinson disease.
Dupixent is the first and only targeted therapy to receive FDA approval for bullous pemphigoid.
Harliku becomes the first FDA-approved treatment for alkaptonuria, indicated to reduce homogentisic acid levels in affected adults.
Approval of first twice-yearly HIV pre-exposure prophylaxis was based on results from the Phase III PURPOSE 1 and PURPOSE 2 trials, which show that ≥99.9% of patients treated with Yeztugo remained HIV-negative.
The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced gadolinium dose, supporting safer repeat use in adults and pediatric patients.
Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
Johnson & Johnson submitted a supplemental Biologics License Application to expand Stelara’s use to children aged two years and older with Crohn disease, supported by data from the Phase III UNITI-Jr trial.
Results from the Phase III TEMPLE trial show that patients administered Qulipta (atogepant) experienced significantly fewer treatment discontinuations due to adverse events compared to topiramate for preventative migraine treatment.
Andembry is the first prophylactic therapy for hereditary angioedema to target factor XIIa, inhibiting the top of the inflammatory cascade that drives attacks.
With acquisition of Verve Therapeutics, Eli Lilly aims to advance next-generation cardiovascular care through one-time gene editing treatments.
Results from the Phase II RedirecTT-1 trial showed a 78.9% overall response with the combination of Talvey plus Tecavli for heavily pretreated patients with relapsed/refractory multiple myeloma and true extramedullary disease.
Strategic actions by Supernus, Teva, Incyte, and BioNTech highlight growing momentum in advancing clinical-stage therapies and precision medicine for high-burden diseases.
Starting July 7, 2025, the two highest doses of Zepbound will be available for a flat price of $499 per month, with shipments beginning in August.
Under terms of the deal, CSPC will receive $110 million upfront, with potential milestone payments reaching up to $5.22 billion, in addition to single-digit royalties.
mRESVIA is now authorized for use in adults aged 18–59 years with an increased risk of respiratory syncytial virus-related lower respiratory tract disease.
Keytruda marks the first perioperative anti-PD-1 treatment option for adults with PD-L1–positive resectable locally advanced head and neck squamous cell carcinoma.
Approval of Zusduri was based on data from the Phase III ENVISION trial, which showed a 78% complete response at three months in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer.
Under terms of the deal, Bharat Biotech will lead late-stage development and scale-up of the altSonflex1-2-3 Shigella vaccine for potential distribution in low- and middle-income countries.
Mavyret marks the first and only direct-acting antiviral approved to treat both acute and chronic hepatitis C virus infections in adults and children aged three years and older, without cirrhosis or with compensated cirrhosis.
