Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity

Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility

Transgene and NEC join forces to advance personalized cancer vaccine

TG4050 harnesses Transgene’s myvac platform and NEC’s AI-powered neoantigen prediction technology to tailor vaccines to each patient’s tumor

ImmunityBio responds to FDA concerns over promotional content

Biocon launches denosumab biosimilars Bosaya and Aukelso in US market

Interchangeable biosimilars to Prolia and Xgeva target osteoporosis and cancer-related bone complications in a $5 billion U.S. market

Lupin wins USFDA nod for generic Dapagliflozin tablets

Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market

Apnimed secures $150 million financing to fuel US launch of oral sleep apnea drug AD109

The financing includes a four-year interest-only period, extendable to five years if a net sales milestone is achieved

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually

EU nod to Rezurock for chronic GVHD in adults & teens

Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation

Aurobindo Pharma’s CuraTeQ achieves Phase 3 success for Omalizumab biosimilar

The drug meets all primary endpoints across 608 patients in Europe and India, strengthening the company's biosimilars pipeline