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Results For "ANDA"

2213 News Found

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


Fermenta Biotech receives EU GMP Certification for its Dahej facility
News | September 23, 2024

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance


Aster DM Healthcare to launch the Rs. 220 crore Women & Children’s Hospital in Hyderabad
Healthcare | September 22, 2024

Aster DM Healthcare to launch the Rs. 220 crore Women & Children’s Hospital in Hyderabad

The exclusive hospital will help address health complexities concerning women and children, specializing in high-end obstetrics, comprehensive gynecological, neonatal & pediatric care


Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.


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