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Results For "USFDA"

1210 News Found

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA
News | August 13, 2025

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA

The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA


Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr
News | August 13, 2025

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY


Briefs: Nectar Lifesciences, Cipla and Marksans Pharma
News | August 12, 2025

Briefs: Nectar Lifesciences, Cipla and Marksans Pharma

Marksans Pharma gets USFDA nod for acid reflux drug


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


Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags
Drug Approval | August 12, 2025

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA


Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr
News | August 08, 2025

Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr

Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore


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


Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs
News | August 06, 2025

Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs

These filings come after FDA issued its latest warning to patients and healthcare professionals about the serious dangers of compounded GLP-1 drugs