Through this approval, Tecentriq-Zepzelca becomes the first and only maintenance therapy to secure FDA clearance to treat ES-SCLC. Image credit: Monster Ztudio via ShutterStock.com. A combination ...

The Trump administration announced Pfizer has agreed to provide all of its medicines at Most Favored Nation (MFN) pricing in Medicaid.

Rocket has pulled an approval application to the FDA, with the biotech considering offloading the asset via external partnerships.

Amgen received a label expansion from the FDA in August 2025, with the VESALIUS-CV data supporting this decision.

The US Food and Drug Administration (FDA) has approved Evita Solutions’ generic form of mifepristone, one of the two medications used in most US abortions, much to the fury of right-wing groups.

Takeda will step away from cell therapy in favour of biologics, small molecules and ADCs in a “strategic portfolio prioritisation”.

With decades of hands-on experience, Sharp’s industry experts reveal their top five recommendations for a timely and compliant drug launch.

The clinical success of CRISPR-based treatments is fundamentally dependent on sophisticated gRNA targeting systems that function as molecular navigators. This explains the biotechnology industry's ...

Though the FDA will continue its core activities, the agency will no longer be accepting NDAs and BLAs until the Republican-Democrat stalemate is resolved.

During HUAWEI CONNECT 2025, Leo Chen, Senior Vice President, President of Enterprise Sales, Huawei, emphasised the focus is ...

Though unexpected CRLs issued by the FDA have caused ripples in the industry, Becky Wood believes that these cases are the ...