Dr. Laura Niklason, President and CEO of Humacyte, Inc. (NASDAQ:HUMA), responded to a New York Times (NYSE:NYT) article that questioned the FDA’s approval of Symvess for commercial sales earlier this ...

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...

Larimar Therapeutics, Inc. (Nasdaq: LRMR) has announced significant progress in its nomlabofusp program for Friedreich’s ...

Total Revenues in 2024 reached $492 million, representing a 427% increase over prior yearProduct Revenues in 2024 reached $273 million, ...

We recently published a list of 10 Hot Biotech Stocks Under $5. In this article, we are going to take a look at where Kodiak ...

Fresenius said the U.S. Food and Drug Administration has approved a biologics license application for its operating company's bone-disease drugs. The approval concerns Fresenius Kabi's Conexxence and ...

We forecast WuXi's revenue growth to be slower than that of other well-established peers. The risk is high that the US Biosecure Act will become law, and we expect global pharmaceutical or ...

Apitegromab, a fully human monoclonal antibody, works by selectively binding to the pro- and latent forms of myostatin in order to inhibit myostatin activation.

A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.

Apitegromab is an investigational treatment aimed at improving motor function for people living with spinal muscular atrophy. Scholar Rock said it has also submitted and received validation for its ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

BBB is already working with ethicists and regulatory experts to ensure its technology is developed responsibly.