Blujepa (gepotidacin) is the first new antibiotic class approved in nearly 30 years, providing a crucial treatment option for drug-resistant urinary tract infections (UTIs). In clinical trials ...

Shares of Solano Therapeutics are surging after winning US FDA approval for its new drug to treat excessive hunger and people with Prader-Willi syndrome, a genetic disorder that leads to physical ...

The domestic pharmaceutical company HLB and China's Antengene Corporation's new drug for liver cancer did not receive approval from the U.S. Food and Drug Administration (FDA). They attempted a ...

NEW YORK — Akero Ther­a­peu­tics may not have ad­e­quate da­ta for ac­cel­er­at­ed ap­proval of its MASH drug, de­spite show­ing it may re­verse cir­rho­sis in pa­tients with … ...

Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular-related death and hospitalizations. This indication was ...

Alnylam Pharmaceuticals Inc. won a major FDA approval on Thursday, one that could propel the Cambridge company toward a major milestone — finally reaching profitability. Alnylam Pharmaceuticals ...

Alnylam's Amvuttra first to treat both nerve and heart forms of ATTR-CM Pricing strategy crucial for Amvuttra's market share against oral options Alnylam is banking on the success of the drug ...

has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this ...

In arguably the biggest Trump-era approval for an ASX biotech, Nanosonics (ASX:NAN) has won FDA assent to sell its next-generation probe sterilising device in the US market. The device, Coris, is for ...

The FDA approval of Alnylam’s Amvuttra sets up a three-way race with Pfizer and BridgeBio, which both market transthyretin stabilizers for transthyretin amyloid cardiomyopathy. There’s a new player on ...

Eli Lilly has launched its diabetes and weight-loss drug Mounjaro in India after receiving regulatory approval. With rising obesity and diabetes rates, India presents a significant market opportunity ...

The Trump administration approved Venture Global’s liquefied natural gas export project in Louisiana more than a year after the project was stalled by a controversial pause on approvals by the ...