Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 126

Results For "U.S"

1563 News Found

USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19
News | April 04, 2022

USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19

If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients


USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma
Biotech | April 03, 2022

USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma

Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --


Oragnon enters global licencing agreement with Dare Biosciences
News | April 01, 2022

Oragnon enters global licencing agreement with Dare Biosciences

An estimated 21 million American women experience BV


Evonik restructures health care business
News | April 01, 2022

Evonik restructures health care business

The new structure further transitions the Health Care business line into a system solutions partner for the pharmaceutical and biotech industries


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


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


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


Dysval gets regulatory approval in Japan
Drug Approval | March 29, 2022

Dysval gets regulatory approval in Japan

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients


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