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Results For "NDA"

4066 News Found

Merck receives EC approval for Winrevair for treatment of PAH
Drug Approval | August 27, 2024

Merck receives EC approval for Winrevair for treatment of PAH

Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe


Shilpa Medicare receives USFDA approval for Bortezomib injection
Drug Approval | August 27, 2024

Shilpa Medicare receives USFDA approval for Bortezomib injection

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)


Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Bristol Myers Squibb to present data across cardiovascular portfolio at ECS 2024
News | August 27, 2024

Bristol Myers Squibb to present data across cardiovascular portfolio at ECS 2024

New analyses, including presentations on mavacamten, apixaban and milvexian, further solidify the company's strength and expertise as a leader in cardiovascular diseases


Pfizer launches digital platform ‘PfizerForAll’
Digitisation | August 27, 2024

Pfizer launches digital platform ‘PfizerForAll’

PfizerForAll works within the existing healthcare system and through a growing network of partners to simplify access via established channels and to close gaps in care


Merck announces Phase 3 trial initiation for Bomedemstat
Clinical Trials | August 27, 2024

Merck announces Phase 3 trial initiation for Bomedemstat

The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)


Akums Q1 FY25 revenue up 5.1%
News | August 26, 2024

Akums Q1 FY25 revenue up 5.1%

The new Injectable Facility housed in Akums Healthcare started commercial production on 22nd August 2024, with a capacity of 362 million units annually


Honeywell launches quality management system HQMR for Life Sciences industry
News | August 26, 2024

Honeywell launches quality management system HQMR for Life Sciences industry

Honeywell Quality Management Review helps manufacturers boost efficiency and quality compliance


Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Clinical Trials | August 26, 2024

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India


BI Sky Global successfully completes FDA MoCRA registration
Drug Approval | August 25, 2024

BI Sky Global successfully completes FDA MoCRA registration

MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States