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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


Alumis reports breakthrough Phase 3 results for oral psoriasis therapy
Clinical Trials | January 08, 2026

Alumis reports breakthrough Phase 3 results for oral psoriasis therapy

The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data


Alzheimer’s could soon be detected with a simple finger-prick
R&D | January 08, 2026

Alzheimer’s could soon be detected with a simple finger-prick

Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives


Rapid-acting ADHD treatment Azstarys now approved in China
Drug Approval | January 08, 2026

Rapid-acting ADHD treatment Azstarys now approved in China

ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood


Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Drug Approval | January 08, 2026

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations


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


Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
Clinical Trials | January 08, 2026

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety


ICMR & Panacea Biotec complete enrollment for India's first indigenous dengue vaccine phase 3 study
Clinical Trials | January 08, 2026

ICMR & Panacea Biotec complete enrollment for India's first indigenous dengue vaccine phase 3 study

DengiAll will be the first indigenous single-shot dengue vaccine in India and is expected to enter the markets by 2027


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


MetaVia’s DA-1726 shows breakthrough weight loss in Phase 1 trial
Biotech | January 07, 2026

MetaVia’s DA-1726 shows breakthrough weight loss in Phase 1 trial

Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit