Each episode of this journey through a disease state contains both a physician guide and a downloadable/printable patient ...

Clinical validation of the Azymetric platform is demonstrated by the accelerated approval of Ziihera® (zanidatamab-hrii), a ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

Understanding biosimilars, biologics, and the challenges surrounding their regulation and pricing in the pharmaceutical ...

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

This partnership comprises a technology transfer of the current drug product manufacturing process for the Chikungunya ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission ...

Once a drug is approved, the specified equipment suppliers ... new modalities while the remainder comes from monoclonal antibodies. Repligen offers investors exposure to the rapidly growing ...

Pfizer partners with Summit Therapeutics to advance cancer treatments using ADCs and ivonescimab. Click here to find out why ...

Kiniksa plans to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025 –– KPL-387 Phase 1 single ascending dose ...

Vimkunya is supplied as an injectable suspension; the vaccine is administered intramuscularly as a single 0.8 mL dose.

Eli Lilly wants to take big swings in Alzheimer’s, ALS, chronic pain and other difficult diseases after its success in ...