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Results For "USFDA"

1404 News Found

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial
Clinical Trials | February 14, 2026

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial

PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients


Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer
News | February 13, 2026

Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components


Lupin Q3 FY26 consolidated PAT jumped 37.4% to Rs.  1,180.5 Cr
News | February 13, 2026

Lupin Q3 FY26 consolidated PAT jumped 37.4% to Rs. 1,180.5 Cr

U.S. market achieved record quarterly sales of Rs. 3,113.2 crore ($350 million), a 54% YoY increase, accounting for 44% of global sales


Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
News | February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway


SPARC announces receipt of priority review voucher associated with Sezaby approval
News | February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases


Yugap Wellness bolsters scientific leadership with Dr Satish Singh appointment
People | January 24, 2026

Yugap Wellness bolsters scientific leadership with Dr Satish Singh appointment

A PhD in Pharmaceutical Sciences, Dr Singh has led global regulatory audits, product validations, and quality systems spanning therapeutic formulations, dietary supplements, and functional foods


FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'
Drug Approval | January 23, 2026

FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'

VETMEDIN (pimobendan) chewable tablets and VETMEDIN solution (pimobendan oral solution) can delay the onset of congestive heart failure (CHF) in dogs


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