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3160 News Found

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


OPPI summit calls for collaboration across stakeholders
News | March 30, 2022

OPPI summit calls for collaboration across stakeholders

The summit also saw the launch of two important reports- Multi-Regional Clinical Trials (MRCT) and Value of OTC in India


GenScript wins Best CDMO award for the third time
News | March 30, 2022

GenScript wins Best CDMO award for the third time

The award also follows GenScript's recognition at the Korea Bioprocessing Excellence Awards in 2021 for the "Best Contract Development and Manufacturing Organization Award".


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


AbbVie to showcase neuroscience portfolio at AAN 2022 annual meeting
Biotech | March 29, 2022

AbbVie to showcase neuroscience portfolio at AAN 2022 annual meeting

AbbVie to present 30 abstracts demonstrating its leadership in neuroscience, including continued migraine treatment research across the spectrum of the disease, commitment to patients with advanced Parkinson's disease, and new studies in spasticity and cervical dystonia