The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of ...

"We are thankful for the steady pace of site activations and continued brisk enrollment with our recently activated sites already contributing,” said Kevin Chung, MD, Chief Medical Officer of SeaStar ...

The FDA's Orphan Drug Designation is intended to encourage the development of treatments for rare diseases. Orphan Drug Designation offers benefits including seven years of market exclusivity ...

Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, ...

J&J is seeking approval of TREMFYA for paediatric conditions with the submission of two sBLA to the US Food and Drug Administration.

Pharmaceutical consultants accelerate the drug development process by applying deep expertise in therapeutic areas.

Stereotaxis' holistic ecosystem approach aims to solve long-standing issues with robotic adoption in EP. See why STXS stock ...

Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

The FDA also used accelerated approval for the initial clearance of asciminib in 2021 for use in CML previously treated with ...

Following the U.S. Food and Drug Administration extending the review period for the company's New Drug Application (NDA) for ...

MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced ...

The FDA missed its deadline to ban a highly toxic gas found in hair products favored by women of color. Some Oregon women ...