Zydus launches Mirabegron ER Tablets in the US

Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market

Marksans Pharma updates on USFDA inspection at Verna, Goa manufacturing facility

Jubilant Pharmova to close manufacturing operations of Solid dosage formulation facility of Jubilant Cadista USA

The US Generics market has been witnessing significant pricing pressure leading to significant losses at Jubilant Cadista since FY2022 onwards.

Fresenius Kabi USA flies complaint against NATCO Pharma

Natco Pharma intends to defend the matter accordingly

Jubilant Pharmova’s Roorkee unit gets VAI status

FDA has concluded that this inspection is 'closed'

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections

AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer

Longest survival follow-up ever reported for immunotherapy treatment in this setting

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva