Texas, USA-based clinical-stage biopharma Savara (Nasdaq: SVRA) on Tuesday announced that the company received a refuse to ...

The FDA has accepted for Priority Review the BLA for sibeprenlimab for the treatment of immunoglobulin A nephropathy in adults.

Candel Therapeutics stock rose after its prostate cancer therapy, CAN-2409, received FDA RMAT designation. This expedites ...

The author has a $2.75 Price Target on CytoDyn (CYDY) in the Next 6 to 12 months, representing significant upside from its ...

BOSTON & MONTREAL, May 28, 2025--enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, ...

Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on ...

Moderna has withdrawn the BLA for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after consulting with FDA.

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions ...

The FDA's RMAT designation is intended to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious or life-threatening diseases where ...

Preclinical data has showing compelling findings for HT-KIT among patients with rare and aggressive KIT-driven cancers, ...

The Trump administration’s decision to pull the Covid-19 vaccine from the CDC’s list of recommended shots for healthy ...

Molbreevi – a new inhaled formulation of the well-established and off-patent white blood cell stimulator molgramostim – is ...