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Results For "ANDA"

2356 News Found

Samsung Biologics introduces optimized manufacturing framework ‘ExellenS’
News | October 12, 2025

Samsung Biologics introduces optimized manufacturing framework ‘ExellenS’

ExellenS applies optimized facility designs, equipment, and processes across all sites to ensure equivalency and speed


Thermo Fisher launches new test to assess lung transplant rejection
News | October 10, 2025

Thermo Fisher launches new test to assess lung transplant rejection

New gene expression profiling test enhances precision in assessing lung transplant rejection and injury


Jubilant HollisterStier launches new sterile fill & finish line at its Spokane facility in US
News | October 10, 2025

Jubilant HollisterStier launches new sterile fill & finish line at its Spokane facility in US

The new line features advanced isolator technology to deliver enhanced sterility assurance, throughput and operational precision


Coveris and SABIC pioneer closed-loop recycling for medical packaging
Packaging | October 10, 2025

Coveris and SABIC pioneer closed-loop recycling for medical packaging

The initiative successfully demonstrates that used medical plastic packaging can be recycled and transformed back into new, contact-sensitive medical packaging


Lilly’s Omvoh shows sustained 4-year efficacy in ulcerative colitis
News | October 09, 2025

Lilly’s Omvoh shows sustained 4-year efficacy in ulcerative colitis

Lilly's Omvoh is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive patient outcomes in ulcerative colitis


Datroway delivers first-ever overall survival breakthrough in 1st-line metastatic triple-negative breast cancer without immunotherapy
Clinical Trials | October 07, 2025

Datroway delivers first-ever overall survival breakthrough in 1st-line metastatic triple-negative breast cancer without immunotherapy

Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population


Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets
Drug Approval | October 07, 2025

Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy


FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL
Drug Approval | October 07, 2025

FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older


PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies
Biotech | October 07, 2025

PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies

New offering to debut at the 32nd ESGCT Congress, October 7–10, 2025, in Seville, Spain


Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups
Policy | October 06, 2025

Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups

States exhorted to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment