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Results For "pulmonary-arterial-hypertension"

25 News Found

Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR
News | November 26, 2024

Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR

WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality


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


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25
Drug Approval | May 10, 2024

Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25

Receives 3 final and 2 tentative product approvals thus far in Q1FY25


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


Granules India received ANDA approval for Sildenafil for oral suspension
Drug Approval | December 06, 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million


Zydus receives final approval from the USFDA for Tadalafil Tablets USP
Drug Approval | June 08, 2023

Zydus receives final approval from the USFDA for Tadalafil Tablets USP

Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)


Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH