The Food and Drug Administration (FDA) is reportedly in discussions with OpenAI to expedite the drug approval process using ...

Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

The US Food and Drug Administration (FDA) has announced that all its centres will operate on a common generative artificial ...

Indian pharmaceutical stocks fell sharply after U.S. President Donald Trump announced a push to lower domestic drug prices ...

FDA will implement a secure generative AI system across all centers by June 30, aiming to streamline internal reviews and ...

The Indian government is refining biosimilar drug regulations, aligning with global standards to ensure stringent quality in ...

President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines ...

However, as groundbreaking as these therapies are, they also pose unique challenges for the drug development process ... accelerated development timelines, and how advanced technologies are ...

A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.