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Results For "US-FDA"

342 News Found

Bengaluru’s STEERLife  and Bionpharma secure USFDA nod for generic HIV drug
Drug Approval | January 14, 2026

Bengaluru’s STEERLife and Bionpharma secure USFDA nod for generic HIV drug

Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing


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


Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment
Biotech | January 12, 2026

Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment

CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration


MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy
Clinical Trials | January 12, 2026

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms


FDA rejects Vanda’s jet lag drug in current form
Drug Approval | January 12, 2026

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning


Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis
News | January 09, 2026

Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis

The FDA designation follows visual-function results from the Phase 2 ACUITY trial


BeOne Medicines wins first-in-world nod for Sonrotoclax in China
Drug Approval | January 09, 2026

BeOne Medicines wins first-in-world nod for Sonrotoclax in China

The approval is backed by data showing deep, durable responses and manageable tolerability


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


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