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Results For "submission"

300 News Found

Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
News | August 29, 2025

Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial

Triggering global regulatory submissions this year for the treatment of obesity


Zydus Therapeutics reports positive phase-3 results in rare liver disease
News | August 29, 2025

Zydus Therapeutics reports positive phase-3 results in rare liver disease

Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients


Gilead’s Yeytuo approved in EU for HIV prevention
Drug Approval | August 28, 2025

Gilead’s Yeytuo approved in EU for HIV prevention

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option


Vivo Bio Tech secures pre-clinical testing contract valued at Rs.10.75 Cr
News | August 22, 2025

Vivo Bio Tech secures pre-clinical testing contract valued at Rs.10.75 Cr

Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies


Boehringer’s lung cancer medicine gets FDA approval
Drug Approval | August 12, 2025

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC


Lupin partners with Sadoz to commercialise Ranibizumab biosimilar
News | August 12, 2025

Lupin partners with Sadoz to commercialise Ranibizumab biosimilar

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A


Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr
News | August 08, 2025

Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr

Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025


AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
Drug Approval | August 06, 2025

AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients

The submission is supported by positive results from the Phase 3 AMPLIFY trial


Johnson & Johnson submits additional data to FDA on psoriatic arthritis
News | August 03, 2025

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025