Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 46

Results For "U.S"

1563 News Found

Gilead Sciences breaks ground on new manufacturing and technical development site in US
News | September 09, 2025

Gilead Sciences breaks ground on new manufacturing and technical development site in US

New Bay Area building marks significant progress as part of $32 billion US investment projected to create $43 billion in economic value


USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Drug Approval | September 08, 2025

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


HealthEdge and UST HealthProof Merge to create AI-powered healthcare payer technology
Digitisation | September 08, 2025

HealthEdge and UST HealthProof Merge to create AI-powered healthcare payer technology

Combination creates a leading, next generation claims operating system for payers, with end-to-end AI capabilities for claims, payments, care & utilization management, payment integrity, and member engagement, serving 115+ health plans


FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease
Drug Approval | September 08, 2025

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD


FDA completes inspection at Biocon Biologics' facility in Bengaluru
News | September 05, 2025

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations


Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
News | September 05, 2025

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


FDA expands medtronic MiniMed 780G system
Drug Approval | September 05, 2025

FDA expands medtronic MiniMed 780G system

Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity


Syntegon reports H1 2025 EBITDA higher by 41% to €127 million
News | September 04, 2025

Syntegon reports H1 2025 EBITDA higher by 41% to €127 million

Free cash flow also reached €63 million, representing an 11 percent increase compared to the high benchmark set in 2024


FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC
Drug Approval | September 03, 2025

FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations