We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
TLX66 was previously granted Orphan Drug status by the European Medicines Agency, but has not yet received a marketing authorization in Europe. Read More
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. Read More
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. Read More
Amylyx’s amyotrophic lateral sclerosis candidate goes before the FDA today, the sole survivor in an investigational minefield that continues to explode clinical trials. Read More
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. Read More
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. Read More
The U.S. government is pulling GlaxoSmithKline’s and Vir Technology’s investigational monoclonal antibody for COVID-19 from certain states where cases of the new subvariant of Omicron, BA.2, are high, as tests have shown that the treatment isn’t effective against the new strain. And the FDA has amended sotrovimab’s Emergency Use Authorization (EUA) accordingly. Read More