Shares of Alvotech ALVO, a biotechnology company specializing in the development and manufacturing of biosimilar medicines, ...

If approved, Joenja will be the first approved treatment in the U.S. for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome ...

Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of ...

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of ...

No Clinical Safety or Efficacy Concerns Currently Identified Agency Feedback Primarily Focused on CMC-Related RequestsCompany Plans Prompt ...

Shares of Replimune Group REPL soared 85.7% on Friday after the company announced that it had aligned with the FDA on the ...

US FDA accepts Pharming’s supplemental NDA resubmission for Joenja to treat children aged 4 to 11 years with APDS: Leiden, the Netherlands Saturday, June 6, 2026, 13:00 Hrs [IST ...

(RTTNews) - Iterum Therapeutics (ITRM) announced the FDA has acknowledged receipt of the resubmission of the New Drug Application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated ...

Please provide your email address to receive an email when new articles are posted on . The FDA has accepted the resubmission of a new drug application for a novel, oral therapeutic intended to treat ...

After submitting its timed-release version of a decades-old ADHD drug to the FDA nearly a year ago, Kansas City's Cingulate ...