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Results For "approval"

2477 News Found

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder
Biotech | January 20, 2026

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder

Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector


EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy
News | January 17, 2026

EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy

Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike


Boston Scientific to acquire Penumbra in $14.5 billion deal
News | January 17, 2026

Boston Scientific to acquire Penumbra in $14.5 billion deal

Penumbra projects fourth-quarter revenue growth of 21.4% to 22.0%, with full-year 2025 revenue expected to reach approximately $1.4 billion


Venus Remedies secures marketing authorisation for Ceftazidime + Avibactam in Indonesia
News | January 16, 2026

Venus Remedies secures marketing authorisation for Ceftazidime + Avibactam in Indonesia

Approval marks Venus Remedies’ first anti-infective marketing authorization in Indonesia and enables the country’s first generic entry for this critical antibiotic combination


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


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


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


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