The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
For Orthocell Ltd (ASX:OCC, OTC:ORHHF), the focus in 2026 is no longer on regulatory milestones. With US FDA approval secured ...
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...
The U.S. 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 ...
Add Yahoo as a preferred source to see more of our stories on Google. The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, ...
The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 ...
Zydus receives US FDA tentative approval for dapagliflozin tablets, 5 mg and 10 mg: Our Bureau, Mumbai Wednesday, February 4, 2026, 17:05 Hrs [IST] Zydus Lifesciences Limited has ...
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