Tag: FDA
Sun Pharma announces US FDA acceptance of sBLA application for ILUMYA...
If the sBLA is approved, expansion into psoriatic arthritis would build on the established clinical experience of ILUMYA as an IL-23 inhibitor for moderate-to-severe plaque psoriasis; FDA decision expected by October 29, 2026
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
Qure.ai nets six new indications cleared by FDA, taking the chest...
Latest solution identifies, highlights & categorizes key positive findings to support clinicians, taking total FDA cleared indications to 26
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
“Our focus is on identifying biological mechanisms that may offer alternative...
Venkat Nelabhotla, Co-Founder, President, and CEO of Vyome Holdings, Inc. shared his insights on the company's long-term vision, its current focus areas, R&D efforts and future outlook
Sentynl Therapeutics announces FDA approval of ZYCUBO
Now the first and only therapy approved for the treatment of Menkes disease in the United States
Vyome reports positive final phase 2 results for VT-1953; Plans to...
Based on these positive Phase 2 results, the company plans to advance VT-1953 into a pivotal study following discussions with the FDA to seek approval to enter $1B potential addressable market opportunity
Lupin receives approval from U.S. FDA for biosimilar Armlupeg™ (Pegfilgrastim-unne)
The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval.
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