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Results For "MAA"

48 News Found

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Clinical Trials | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign
Policy | January 07, 2025

1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign

Nadda chairs Joint Strategy Meeting with Line Ministries for TB Mukt Bharat Abhiyan- 100-Day Intensified Campaign


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population


Bayer strengthens pharma portfolio with new cardiology drug acoramidis
News | March 06, 2024

Bayer strengthens pharma portfolio with new cardiology drug acoramidis

Acquisition of exclusive commercialization rights for European markets


Ministry of Ayush and Ministry of Women and Child Development join hands for Nutritional Improvement in adolescent girls through Ayurveda interventions
News | February 27, 2024

Ministry of Ayush and Ministry of Women and Child Development join hands for Nutritional Improvement in adolescent girls through Ayurveda interventions

Both the Ministries signed MoU for anaemia control among adolescent girls using Ayurveda interventions


FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting


Brenntag Specialties and Zeochem expand collaboration for Pharma EMEA
Supply Chain | November 17, 2023

Brenntag Specialties and Zeochem expand collaboration for Pharma EMEA

Collaboration enables Brenntag to serve pharma customers in EMEA with chromatography silica gels


Apitoria Pharma  appoints Dr. Sanjay Chaturvedi as CEO
People | April 06, 2023

Apitoria Pharma appoints Dr. Sanjay Chaturvedi as CEO

Venkat Nageswar Chalasani has been appointed as an Independent Director of Apitoria Pharma with effect from April 4, 2023