Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...

Kaizen Biosciences, Co., a Philadelphia-based biopharmaceutical firm, is making strides toward regulatory approval for its novel pediatric antibiotic formulation, following the acceptance of new ...

Supporters believe that FDA approval will make the drug more accessible. Right now, traditional psilocybin therapy offered at healing centers in the state is not covered by insurance.

Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced ...

BOSTON—FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA”—one that would decide on drug applications much faster, partner with industry, and apply artificial ...

Aldeyra's reproxalap new drug application (NDA) was previously rejected due to efficacy concerns, despite no safety or manufacturing issues. The latest NDA includes successful dry eye chamber trial ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic ...

The FDA has accepted a new drug application (NDA) for zoliflodacin, an investigational first-in-class, single-dose, spiropyrimidinetrione oral antibiotic for the treatment of adult and pediatric ...

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U ...

U.S. FDA Accepts New Drug Application Under Priority Review for sevabertinib (BAY 2927088) in HER2-Mutant Non-Small Cell Lung Cancer ...

SHANGHAI and SAN DIEGO, May 22, 2025 /PRNewswire/ -- FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 ...

Similar to seeking FDA approval for initial uses for new drugs, manufacturers must submit applications for approval for these new uses – this application process may involve a supplement to the ...