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5713 News Found

USFDA grants appeal for Ardelyx's XPHOZAH
Drug Approval | December 31, 2022

USFDA grants appeal for Ardelyx's XPHOZAH

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


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


Claim against Dr. Reddy’s Laboratories dismissed over Revlimid in US
News | December 30, 2022

Claim against Dr. Reddy’s Laboratories dismissed over Revlimid in US

All claims against the company in the litigation have now been dismissed.


Mandaviya and Puri hail MoU between IndianOil and Central TB Division for states of UP and Chhattisgarh
Policy | December 29, 2022

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
Drug Approval | December 29, 2022

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


Amcor sells factories in Russia
Packaging | December 28, 2022

Amcor sells factories in Russia

The cash and debt free consideration value is €370 million.


Alembic receives USFDA final approval for Fulvestrant Injection
Drug Approval | December 27, 2022

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


Hetero's COVID-19 oral drug gets WHO prequalification
News | December 27, 2022

Hetero's COVID-19 oral drug gets WHO prequalification

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission


NAFLD clinical trial activity catching up in China but lacks substantial domestic participation, says GlobalData
News | December 27, 2022

NAFLD clinical trial activity catching up in China but lacks substantial domestic participation, says GlobalData

China has the highest number of clinical trials that were initiated in NAFLD in the APAC region over the past decade.