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Results For "regulatory"

1533 News Found

GRIN Therapeutics launches global Phase 3 trial for groundbreaking GRIN-NDD therapy
Clinical Trials | January 14, 2026

GRIN Therapeutics launches global Phase 3 trial for groundbreaking GRIN-NDD therapy

GRIN-NDD is one of the most complex neurodevelopmental disorders with limited treatment options today


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


Aragen slashes drug development time with CHOMax platform
News | January 12, 2026

Aragen slashes drug development time with CHOMax platform

CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes


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


NAMSA expands US footprint with Labcorp medical device testing acquisition
News | January 12, 2026

NAMSA expands US footprint with Labcorp medical device testing acquisition

The deal brings Labcorp’s U.S. portfolio—including biocompatibility, microbiological, and analytical testing, as well as preclinical research—under NAMSA’s roof


Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera
News | January 11, 2026

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories


Prokaryotics and Basilea team up to tackle deadly fungal infections
Biopharma | January 11, 2026

Prokaryotics and Basilea team up to tackle deadly fungal infections

The partnership aims to develop a first-in-class broad-spectrum antifungal to combat life-threatening invasive infections


Shilpa Medicare aims for US approval of chemo nausea drug
News | January 09, 2026

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections


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