USFDA grants appeal for Ardelyx's XPHOZAH

Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism

Mandaviya and Puri hail MoU between IndianOil and Central TB Division for states of UP and Chhattisgarh

This ambitious anti-TB campaign, as part of IOCL’s CSR, aims to ensure early identification of presumptive TB and prompt diagnosis using high-sensitivity diagnostic tests at the doorstep

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore

Hester to develop low pathogenic avian influenza inactivated vaccine for poultry

The company has plans to launch this Vaccine by the end of 2023 after completing the required field studies and obtaining regulatory approvals

World's first intranasal vaccine iNCOVACC will be rolled out in the fourth week of January

The vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunization during public health emergencies and pandemics

Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies

Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze

Alembic receives USFDA final approval for Fulvestrant Injection

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US $71 million for twelve months ending Sep 2022 according to IQVIA

Lupin receives USFDA approval for Brivaracetam Tablets

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH

Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules

Pregabalin Capsules have an estimated market size of US $244 million for twelve months ending Sep 2022 according to IQVIA