Tag: US
Aurigene wins RE Pharma award; contributes to two US FDA Novel...
In a significant milestone year, Aurigene also served as the primary API manufacturer for two of the 46 Novel Drug Approvals granted by the (USFDA) in 2025
AbbVie’s $100 billion US deal & FDA reforms highlight growing focus...
Coupled with the evolving US Food and Drug Administration manufacturing reforms, the deal underscores a policy-driven shift
ErlySign granted US FDA breakthrough device designation for its saliva-based oral...
The designation marks a significant global regulatory milestone for the company and underscores the potential of its technology to advance early cancer detection across international markets
Pandorum Technologies raises US$18 Million in Series B to advance global...
Funding accelerates clinical development and market access across the U.S., Asia, and the Middle East
Samsung Bioepis flags shifting PBM models and deepening price erosion in...
Q1 2026 Biosimilar Market Report tracks approvals, launches, pricing trends, and the potential impact of evolving PBM rebate frameworks on biosimilar uptake
Bipolar disorder market across 7MM set to grow at 5.3% CAGR...
GlobalData forecasts that the late-stage pipeline products could drive combined sales of approximately $2.8 billion by 2034 in the 7MM
Biocon Biologics secures market entry date for Denosumab biosimilars in...
The agreement allows the company to commercialize both its Denosumab biosimilars (Vevzuo® and Evfraxy®) in Europe starting December 2, 2025
Harmonization of standards, AI & technology, supply chain growth key for...
The speakers said that the unique experience of both the countries would prove to be complementary and beneficial to each other
Lupin Bioresearch Center receives zero observations from US-FDA
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
Biocon Biologics and Civica expand partnership to launch private-label Insulin Glargine...
Additional treatment options for the 38.4 million U.S. patients living with diabetes