In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions…
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee yesterday declined by a vote of 6-4 to recommend approval of Amylyx Pharmaceuticals’ AMX0035, a drug intended to treat amyotrophic…
The FDA has issued warning letters to two companies for making implied claims that their products could prevent or treat COVID-19, making them unapproved new drugs in the agency’s eyes.…
The first-line oral diabetes drug metformin has been linked to 40 percent higher risk of birth defects in the offspring of men who took it during the three months before…
Sanofi and IGM Biosciences have signed an agreement to create, develop, manufacture and commercialize immunoglobulin M (IgM) antibody agonists against three oncology targets and three immunology/inflammation targets. Source: Drug Industry…
The FDA has authorized second booster doses of the Pfizer and Moderna COVID-19 vaccines for adults aged 50 years and older and younger immunocompromised individuals. Source: Drug Industry Daily
Amylyx’s amyotrophic lateral sclerosis candidate goes before the FDA today, the sole survivor in an investigational minefield that continues to explode clinical trials. Source: Drug Industry Daily
President Biden submitted his fiscal 2023 budget request yesterday, seeking an $8.4 billion budget for the FDA for fiscal year 2023, a whopping 34 percent increase from fiscal 2022. Source:…
Three antibodies directed at interleukins — inflammatory proteins associated with a number of skin disorders — posted positive phase 3 results and were touted at the annual meeting of the…
The price of U.S. cancer drugs keeps climbing despite market competition, while the costs of the same drugs have stayed relatively flat or have actually decreased in Germany and Switzerland.…