Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

FDA Commissioner Dr. Marty Makary announces the acceptance of broader real-world data in medical applications, ending previous requirements that limited submissions.

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

Discovering effective drug combinations may now be easier thanks to a screening platform made public today by St. Jude ...

The firm will share updated data and new analyses from its Phase III trial with the agency, which issued a complete response ...

We found that one-third of pharmaceutical companies proactively released the launch price of their medications between 2022 and 2024, and another third released them reactively. Smaller public ...

Pilatus Biosciences Announces FDA Clearance of IND Application for PLT012, a First-in-Class Anti-CD36 Metabolic Checkpoint ...

Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted ...

Medetomidine, a veterinary sedative mixed into fentanyl, has sent thousands to hospitals, not only for overdose but for life-threatening withdrawal. It is spreading to other cities.