Pharma News, 2023

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced interim results from its pivotal Phase 3 safety and immunogenicity trial...

The Chiesi Group has received FDA approval for Lamzede (velmanase alfa-tycv) for treatment of adult and pediatric patients with non-central nervous system manifestations of alpha-mannosidosis, a ra...

The risk of new-onset cardiometabolic diseases was significantly elevated post-COVID-19 infection compared to pre-COVID-19 infection.

Daiichi Sankyo has succeeded in a bid to convince the US Patent and Trademark Office (PTO) to take another look at a patent held by Seagen that was previously deemed to have been infringed by its b...

Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to FILSPARI™ (sparsentan) to reduce proteinuria in adul...

Maze Therapeutics, a company translating genetic insights into new precision medicines, has announced that the company will present data from its first-in-human clinical trial of MZE001 for Pompe d...

Aqilion AB announced an exclusive license and strategic research collaboration with Merck to discover, develop and commercialize small molecule inhibitors of the transforming growth factor-ß-activ...

The Secretary of the US Department of Health and Human Services (HHS) has selected three new models for testing by the Centers for Medicare & Medicaid Services’ (CMS) Innovation Center to hel...

The FDA has issued a complete response letter (CRL) to Biocon and Viatris over their biologics license application (BLA) for bevacizumab, a proposed biosimilar of Roche’s blockbuster cancer drug ...

Kinnate Biopharma received Fast Track status for its KIN-3248 drug, an investigational candidate for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma h...

The FDA has updated the labeling for Biogen’s Alzheimer’s drug Aduhelm (aducanumab-avwa) to include a warning of potential amyloid-related imaging abnormalities (ARIA), which can lead to brain ...

The FDA has issued Soligenix a Refusal to File letter for its HyBryte (synthetic hypericin) new drug application (NDA), deeming it not sufficiently complete for a substantive review. ...