Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application

Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025

Lupin receives FDA’s tentative approval for Siponimod tablets

Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs

Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia

The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

Roche wins EU green light for one-minute injection cancer therapy

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options

FDA concludes Lupin’s Nagpur Unit-1 facility inspection with zero observations

Merck KGaA Q3 2025 net sales remains flat amid geopolitical uncertainty