The acquired portfolio consists of 13 ANDAs already approved by the Food and Drug Administration and one pending approval.

PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

This approval positions Lupin to tap into a substantial market opportunity for a drug indicated for the treatment of ...

One of the most highly anticipated FDA decisions this month is for Alnylam Pharmaceuticals, which is seeking to expand the ...

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...

Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively. A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the ...

Ivor Elrifi, CEO of Tiziana Life Sciences, expressed enthusiasm about this milestone, stating, "We are excited to initiate this important clinical study with the support of the ALS Association grant.

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...