Don Tracy, Associate Editor

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.

Approval was based on results from the Phase II TRUST-I and TRUST-II trials, which demonstrated confirmed overall response rates of up to 90% in patients treated with Ibtrozi for locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Delivered as a once-daily 30 mg/mL IV bolus injection over 15 seconds, Xifyrm can be used alone or alongside non-NSAID analgesics as part of a multimodal pain strategy.

Regulatory action was based on data from the Phase III IMforte trial, which showed that Zepzelca plus Tecentriq significantly extended both progression-free survival and overall survival in patients with extensive-stage small cell lung cancer.

Results from a first-in-human Phase Ia/Ib trial show that LY4170156 demonstrated a notably high overall response rate in women with heavily pre-treated, platinum-resistant ovarian cancer.

Ron Lanton, Partner, Lanton Law, discusses the constitutional and statutory challenges facing the President’s use of executive orders to implement international drug pricing models such as the Most Favored Nation, highlighting the ongoing debate over separation of powers and congressional authority.

Approval of Enflonsia was based on data from the Phase IIb/III CLEVER trial, which showed a 60.5% reduction in medically attended lower respiratory infections and an 84.3% reduction in respiratory syncytial virus-related hospitalizations.

Early Phase I results for JNJ-79635322 demonstrated an 86.1% overall response rate in heavily pretreated multiple myeloma patients, including a 100% response in those naïve to B-cell maturation antigen and GPRC5D therapies.

Widaplik marks the first and only FDA-approved triple combination medication that can be used as an initial therapy for patients with hypertension who require multiple drugs to reach their blood pressure reduction goals.

Ron Lanton, Partner, Lanton Law, outlines how the MFN executive order may face significant legal challenges from the pharmaceutical industry, citing concerns over due process, intellectual property, and regulatory overreach.