National Epidemiologist Dr. Shallaudin Ahmed has assured the public that the Ministry of Health’s surveillance system remains ...

Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced ...

This is a groundbreaking step toward advancing public health by using more effective and human-relevant methods instead of ...

Research has shed light on how a new type of antibody treatment reactivates patients' immune cells to fight ovarian cancer.

PETA and other animal advocacy groups have praised the Trump administration for recent announcements to phase out animal ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal ...

The U.S. Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies and ... before they can test a new therapy in humans, they must show proof ...

However, the MDA is silent on laboratory tests developed by clinical laboratories for their own use or LDTs. Instead, LDTs have been regulated by CMS under CLIA. In 2021, a bill that would have ...

The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said that would raise the cost and force labs to stop creating tests that ...

The purification of proteins and antibodies is a critical process in biotechnology and pharmaceutical industries. Traditional methods often involve single-use materials, leading to high costs and ...

The court found that the FDA rule would have negatively impacted testing on which patients and clinicians depend, and that the rule also went against Congress' intent, which is for laboratory ...

"ADLM applauds the U.S. District Court for the Eastern District of Texas for issuing a decision to vacate the Food and Drug Administration's (FDA's) final rule to regulate laboratory developed tests ...