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

Skyhawk Therapeutics and Merck KGaA strike $2 billion deal to discover novel RNA for neurological disorders

Skyhawk Therapeutics enters into an option agreement to grant Merck KGaA, Darmstadt, Germany, exclusive global rights to drug candidates pursued under the collaboration upon option exercise

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

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension

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

FDA approves first immunotherapy for recurrent respiratory papillomatosis

Tonix receives FDA approval of Tonmya for treatment of fibromyalgia

From Policy to Practice: How India’s Pharmaceutical Industry is Being Shaped by the PLI Scheme – by Vikram Aditya Sehgal, Director – Finance, Centrient India

The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations

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