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1679 News Found

USFDA seeks more analysis on Merck’s BLA for Vaxneuvance
Biotech | April 01, 2022

USFDA seeks more analysis on Merck’s BLA for Vaxneuvance

No new studies have been requested


CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds
Biotech | March 31, 2022

CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds

Air purification system achieves Intertek zero ozone certification


USFDA approves Edwards Mitris Resilia valve
Medical Device | March 31, 2022

USFDA approves Edwards Mitris Resilia valve

The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve


Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors
Drug Approval | March 30, 2022

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding


USFDA approves CartiHeal's implant for the treatment of cartilage and osteochondral defects
Drug Approval | March 30, 2022

USFDA approves CartiHeal's implant for the treatment of cartilage and osteochondral defects

Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies


Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes
Drug Approval | March 29, 2022

Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults


USFDA clears IND application for an intranasal RSV vaccine
Biotech | March 29, 2022

USFDA clears IND application for an intranasal RSV vaccine

The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers


USFDA approves EUA for second booster dose of Moderna
News | March 29, 2022

USFDA approves EUA for second booster dose of Moderna

50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age


EU and European Disability Forum laud efforts of Sightsavers in India
Public Health | March 28, 2022

EU and European Disability Forum laud efforts of Sightsavers in India

This targeted capacity-building and advocacy project in 15 districts and 5 states of India has facilitated the certification of disability for 11,152 people, provided disability pensions to 8,144 people and supported the issuing of voter IDs to 8,450 people with disabilities