If the Trump White House is serious about its push to make medicines more affordable, it should ensure CMS officials never ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers. The Food and Drug ...

Lonza officials say they have expanded the company’s service offering for orally delivered biologic therapies to support the unique development and manufacturing needs of smart capsule companies. Oral ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we ...

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 ...

The U.S. Food and Drug Administration (FDA) today announced action to make it faster and less costly to develop biosimilar medicines, which are lower-cost alternatives to expensive biologic drugs used ...

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 ...

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...

Centre unveil 5-yr Rs 10,000 cr programme to boost domestic biologics & biosimilars, aiming to cut costs import dependence. Speedy approvals for advanced therapies like monoclonal antibodies.

Introduction of biosimilars for the rheumatology drug adalimumab, whose original branded version Humira has long been a blockbuster, appears to have led to a dramatic drop in net spending for these ...