The Food and Drug Administration said it will be taking steps to speed up the approval process for developing generic biological drugs, an effort aimed at increasing cheaper competition among ...

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

Biologic drugs have improved how doctors treat serious illnesses. Instead of being made from chemicals, biologics are made from organic materials and grown in living cells. Biologic drugs are used ...

Biologics are diverse, organic-based treatments like vaccines and gene therapy, requiring specific conditions for effectiveness. Unlike small molecules, biologics show batch variability and involve ...

New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD ...

(CNN) — The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

DUBLIN--(BUSINESS WIRE)--The "Biological Drugs - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. The global market for Biological Drugs was estimated at ...

As more drugs go subcutaneous, Phillips Medisize's director of Front-End Innovation, Tony Bedford, believes that high-dose ...

The FDA recently designated Yuflyma as "interchangeable" with the popular biologic Humira for the treatment of Crohn's disease and ulcerative colitis, two types of inflammatory bowel disease (IBD), ...

SEATTLE--(BUSINESS WIRE)--Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, today announced the closing of a $16 million Series B ...