FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development

Strides partners with Kenox to expand nasal spray portfolio for US market

Kenox to provide formulation and development expertise in orally inhaled and nasal drug products

USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

Glenmark initiates multi-country Phase 3 clinical trial for Envafolimab in resectable Stage III NSCLC

The company has received approval from DCGI to begin patient enrolment and dosing in the country

Poly Medicure to acquire 90% stake in PendraCare Group for € 18.3 million

PendraCare Group develops, manufactures and sells innovative cardiology catheter solutions and provides design, development and manufacturing services to other global OEM’s

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product

CapVest to acquire majority stake in STADA

Bain Capital and Cinven will each retain a minority stake, reflecting their ongoing confidence in STADA’s future growth

Zydus launches VaxiFlu vaccine for flu protection

First Indian company to follow global recommendations in accordance with the World Health Organisation (WHO)

President Murmu graces diamond jubilee celebrations of All India Institute of Speech and Hearing, Mysuru

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported