The combination demonstrated non-inferiority to comparator antiretroviral therapies, meeting the primary efficacy success ...

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

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

PDS Biotechnology (PDSB) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application filed in ...

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, today announced an investment of over $6 million to expand its Rosenberg, Texas manufacturing ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

President and CEO Ned McCoy shared with Becker's some of the company's key objectives for the year, including the launch of some of the first medications from its Petersburg, Va.-based plant, the ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

Zydus Lifesciences receives USFDA approval for Methenamine Hippurate Tablets, strengthening position in US market.

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

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