Zydus Therapeutics reports positive phase-3 results in rare liver disease

Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications

Gilead’s Yeytuo approved in EU for HIV prevention

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option

FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema

Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control

AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib

The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study

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