OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable ...

Nalagenetics, a spin-off from A*STAR GIS, will be implementing a nationwide genetic screening programme in Indonesia with their PGx1301 diagnostic kit for leprosy patients. Set to launch in the fourth ...

A new study reveals that generic drugs manufactured in India have a higher association with severe adverse events such as hospitalization, disability, and death compared to those made in the U.S ...

Generic drugs manufactured in India are linked to significantly more “severe adverse events” for patients who use them than equivalent drugs produced in the United States, a new study finds. These ...

A new study has found that generic drugs manufactured in India are linked to significantly more severe adverse events — including hospitalization, disability and in some cases death — compared ...

In addition, when manufacturers are made aware of adverse reactions to a drug or vaccine, they must report to Health Canada: serious adverse reactions in Canada unexpected serious adverse reactions in ...

Concomitant health products (exclude treatment of action): other health products that were used at the same time as the adverse reaction describe if any drugs or health products are also suspected in ...

FDA proposes draft guidelines on AI use in drug development, addressing challenges and opportunities for improving safety and efficacy.

Drug safety relates to the potential for adverse effects related to the administration of drugs. Efforts to establish the safely profile of drugs begin early in their development, with in vitro ...

Each quarterly data file within the database encompasses essential documents, including DEMO (which contains patient demographic and administrative information, a single record for each event report), ...