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FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease
Drug Approval | September 08, 2025

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD


Aptar Pharma partners with Dianosic to advance ARIS platform for treatment of chronic allergic rhinitis and rhinosinusitis
News | September 08, 2025

Aptar Pharma partners with Dianosic to advance ARIS platform for treatment of chronic allergic rhinitis and rhinosinusitis

Agreement further expands Aptar Pharma’s leading position in nasal delivery solutions and addresses significant unmet needs of delivering drugs locally over extended periods


Zydus Lifesciences appoints Nitin Parekh as President (Special Projects)
People | September 08, 2025

Zydus Lifesciences appoints Nitin Parekh as President (Special Projects)

He has been associated with the Zydus Group since 2009


USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Drug Approval | September 08, 2025

USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe


Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
News | September 05, 2025

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product


CapVest to acquire majority stake in STADA
News | September 05, 2025

CapVest to acquire majority stake in STADA

Bain Capital and Cinven will each retain a minority stake, reflecting their ongoing confidence in STADA’s future growth


Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease
Clinical Trials | September 05, 2025

Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease

RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity


Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure