FDA lifts hold on Rocket Pharma's gene therapy trial

Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort

NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity

NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity

Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial

According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million

Alkem launches ceramide-boosting moisturizing lotion for skin barrier repair

Novo Nordisk's Wegovy approved in the US for the treatment of MASH

The accelerated approval is supported by results from part 1 of the ESSENCE trial

Sarepta advances siRNA collaboration and sale of arrowhead equity investment

Sarepta has also entered into an agreement with Arrowhead to transfer 2,660,989 shares of Arrowhead common stock in satisfaction of $50 million of the company’s previously announced $100 million milestone payment obligation

BioAge Labs doses first patient in BGE-102 phase 1 trial

The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants

Pfizer’s sickle cell disease candidate fails Phase III trial

Inclacumab was generally well tolerated in THRIVE-131

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo

European Commission grants approval of Ogsiveo

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors