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Results For "ANDA"

2607 News Found

Briefs: Eugia Steriles and Shelter Pharma
Drug Approval | September 18, 2024

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility


Merck and Siemens partner on digital transformation technology
News | September 17, 2024

Merck and Siemens partner on digital transformation technology

MoU signed to drive digital transformation through strategic projects across all three business sectors of Merck


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable
News | September 14, 2024

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market


USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations
Drug Approval | September 14, 2024

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices


DFC commits US $20 mn loan to Panacea Biotec towards capacity expansion for hexavalent vaccine
News | September 13, 2024

DFC commits US $20 mn loan to Panacea Biotec towards capacity expansion for hexavalent vaccine

The wP-IPV-based hexavalent vaccination is an innovative immunization alternative to the current pentavalent and standalone IPV vaccines


Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech
News | September 12, 2024

Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility


Pfizer highlights diverse oncology portfolio and combination approaches at ESMO 2024
News | September 11, 2024

Pfizer highlights diverse oncology portfolio and combination approaches at ESMO 2024

More than 10 oral and mini-oral presentations span Pfizer’s extensive Oncology portfolio of approved and investigational therapies


Combination of ‘Siddha’ drugs reduces anemia in adolescent girls: Study
News | September 10, 2024

Combination of ‘Siddha’ drugs reduces anemia in adolescent girls: Study

The study observed 2,648 girls, of which 2,300 completed the standard 45-day programme


Atal Innovation Mission, NITI Aayog hosts 20th MedTech Mitra Technical advisory meeting
Policy | September 10, 2024

Atal Innovation Mission, NITI Aayog hosts 20th MedTech Mitra Technical advisory meeting

MedTech Mitra initiative aims to empower MedTech innovators and advance healthcare solutions