Tag Archives: FDA Approval

In September there was 1 new drug approval by the FDA we deemed specific to the specialty market. In addition, there were 9 supplemental drug approvals. The FDA had acted on assignment of 4 new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

Join RJ’s Jason Young – SVP Clinical Data Operations, Todd Cooperman – SVP Clinical Insights and Analytics, and Chris Webb – Director of Product Development, as they review the drug coding updates, revisions, and issues observed over 2019’s third quarter. October 8th, 2pm EST Learn about: New and Existing Code Updates – HCPCS Codes: J […]

In August there were 4 new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 2 supplemental drug approvals. The FDA had acted on assignment of 5 new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

In July there were six new drug approvals by the FDA we deemed specific to the specialty market, three of the approvals were for biosimilar products. In addition, there were 2 supplemental drug approvals. The FDA had acted on assignment of eight new product reviews. Drugs included in this review are generally regarded by the […]

In June there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 12 supplemental drug approvals. The FDA had acted on assignment of six new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

In May there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 14 supplemental drug approvals. The FDA had acted on assignment of three new product reviews, although no PDUFA dates were published. Drugs included in this review are generally regarded by the industry as […]

In April there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were five supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for six new products for review. Drugs included in this review are generally regarded by the industry as specialty […]

In March there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were four supplemental drug approvals. The FDA had acted on the assignment of new PDUFA dates for ten new products for review. Finally, there was one product that had an extension of a PDUFA […]

In February there were two new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there was one complete response letter issued. Drugs included in this review […]

In January there was one new drug approval by the FDA we deemed specific to the specialty market. In addition, there were three supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there were two complete response letters issued and one manufacturer triggered withdrawal […]