"Pregnant women and their healthcare providers need clear, reliable information to make informed treatment decisions,” said FDA Commissioner Marty Makary, M.D., M.P.H. "This guidance supports better ...

Biologics are typically administered via injection and are thus best designed as liquid parenteral solutions. However, maintaining the stability of liquid biological products can be challenging.

Seul Eunjin, AGC Biologics; Kunii Shigeru, AGC Biologics; Sung Gong, Novelty Nobility; Park Chan-Hee, Novelty Nobility; ...

Patients needing costly biologic drugs for autoimmune and chronic conditions often face insurance denials that delay or block treatment. With strong medical documentation, standardized appeal ...

By Heejin Kim SEOUL, May 4 (Reuters) - South Korean contract drug manufacturer Samsung Biologics estimated a strike by its labour union over pay that started late last month has cost the company about ...

Last year, 43% of U.S. adults did not take their medication as prescribed because of the cost of prescription drugs. These rising drug prices hit American seniors, small businesses, and middle-class ...

Real‑world and prospective data demonstrate the role of clearance‑informed, precision‑guided dosing in supporting ...

Membrane proteins present significant technical challenges in drug discovery, yet their role in biology make them highly ...

Pierre Fabre Pharmaceuticals, Inc. (PFP), announces it has aligned with FDA on a potential path forward for resubmission of the BLA for tabelecleucel, an allogeneic T-cell therapy with a proposed ...

By Yasmeen Abutaleb and Jarrett Renshaw WASHINGTON, May 8 (Reuters) - The White House signed off on a plan to fire U.S. Food and Drug Administration Commissioner Marty Makary, according to sources ...

NN4101, a first-in-class, connects a fully human anti-c-Kit monoclonal antibody with a vascular endothelial growth factor ...