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Results For "USFDA"

1355 News Found

Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline
News | January 23, 2026

Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline

The company has posted net profit of Rs. 4,064.9 crore for the 9 months period ended December 31, 2025


FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer
Drug Approval | January 21, 2026

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells


Mahajan Imaging & Labs launches AI-driven blood test to detect Alzheimer’s early
News | January 20, 2026

Mahajan Imaging & Labs launches AI-driven blood test to detect Alzheimer’s early

Over 8.8?million Indians aged 60 and above currently live with dementia,


Teva’s AJOVY gains spotlight as first preventive migraine treatment for kids
R&D | January 15, 2026

Teva’s AJOVY gains spotlight as first preventive migraine treatment for kids

The findings, from the SPACE study, paved the way for FDA approval of AJOVY for pediatric patients aged 6-17 years weighing 45 kilograms


Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients
Drug Approval | January 14, 2026

Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients

The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes


Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US
News | January 14, 2026

Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is an antihistamine eye drop, indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander


4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy
Drug Approval | January 12, 2026

4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy

Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function


Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer
Drug Approval | January 08, 2026

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer

Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis


Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
Medical Device | January 08, 2026

Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures


Briefs: Medicamen Biotech and Gland Pharma
Drug Approval | January 08, 2026

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)