Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation

Cipla receives two observations following USFDA inspection at Goa facility

The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe

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

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

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

NATCO announces launch of Pomalidomide capsules in US

It is also approved for?AIDS-related Kaposi sarcoma?after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma

Esperion to acquire Corstasis, gaining first FDA-approved nasal spray Diuretic

Lupin Q3 FY26 consolidated PAT jumped 37.4% to Rs. 1,180.5 Cr

U.S. market achieved record quarterly sales of Rs. 3,113.2 crore ($350 million), a 54% YoY increase, accounting for 44% of global sales

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain

Pangea Laboratory teams with Gene Solutions to bring AI-driven cancer tests to US patients

Pangea will use its integrated validation platform and regulatory expertise to oversee analytical and clinical validation of Gene Solutions’ multi-omics technologies.