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Results For "USFDA"

1313 News Found

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia
Drug Approval | November 06, 2025

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia

Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval


Senores Pharma forms new subsidiary in US
News | November 06, 2025

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals


Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg
Drug Approval | November 05, 2025

Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde


Industry leaders call for a new era of collaboration, innovation, and self-reliance
News | November 03, 2025

Industry leaders call for a new era of collaboration, innovation, and self-reliance

Building a transparent, data-driven supply chain and self-reliant API ecosystem remains critical to reducing import dependence


FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes
Drug Approval | October 29, 2025

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms


FDA approves Alembic's Ticagrelor Tablets, 60 mg
Drug Approval | October 29, 2025

FDA approves Alembic's Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients


Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study
Clinical Trials | October 25, 2025

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy


Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection
Drug Approval | October 24, 2025

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable


FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL
Drug Approval | October 19, 2025

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions


Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies
Clinical Trials | October 16, 2025

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies

These findings follow positive Phase 3 results presented earlier this year