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Results For "USFDA"

1452 News Found

Jubilant Pharmova to close manufacturing operations of Solid dosage formulation facility of Jubilant Cadista USA
News | April 19, 2024

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.


Jubilant Pharmova’s Roorkee unit gets VAI status
Drug Approval | April 18, 2024

Jubilant Pharmova’s Roorkee unit gets VAI status

FDA has concluded that this inspection is 'closed'


Alvotech and Teva get US FDA approval of Selarsdi
Drug Approval | April 17, 2024

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


Positive data for Roche multiple sclerosis injection
Drug Approval | April 17, 2024

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024


Briefs: Sun Pharma and Kimia Biosciences
News | April 14, 2024

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA


Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO  International Non-proprietary Names
News | April 02, 2024

Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO International Non-proprietary Names

Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus


Viatris launches RYZUMVl 0.75% in US
News | April 02, 2024

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours


AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Drug Approval | April 02, 2024

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial