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1503 News Found

Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint
News | July 03, 2025

Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint

The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market


Briefs: Neuland Laboratories and Granules India
Drug Approval | June 29, 2025

Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility


Lupin launches Prucalopride tablets in US
Drug Approval | June 27, 2025

Lupin launches Prucalopride tablets in US

Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


Covestro launches localized production of medical-grade TPU in Asia Pacific
Medical Device | June 25, 2025

Covestro launches localized production of medical-grade TPU in Asia Pacific

Changhua site meets international regulatory standards for global medical applications


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Lupin receives USFDA approval for Prucalopride Tablets
Drug Approval | June 25, 2025

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults


Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Clinical Trials | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy


Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia
News | June 21, 2025

Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia

BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population


Sanner commences manufacturing critical injection-molded components in USA
Packaging | June 20, 2025

Sanner commences manufacturing critical injection-molded components in USA

The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space