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By listening to the experiences and concerns of patients with rare diseases, the FDA can get a better picture of the most troublesome symptoms. Read More
The FDA’s guidance on showing effectiveness through a single trial plus confirmatory evidence is off to a good start in offering direction on leveraging real-world data (RWD), but providing more specifics would be highly beneficial, industry comments say as comments close on the agency’s draft guidance. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
Checkpoint Therapeutics announced that the FDA has issued a complete response letter (CRL) for its cosibelimab BLA based on an inspection of the company’s third-party manufacturer, with no issues cited on the approvability of the drug itself. Read More
After 10 months of questions and concerns from antitrust regulators, Pfizer’s colossal $43 billion acquisition of cancer-focused biotech company Seagan is complete. Read More
Over the past week, the FDA issued draft guidance on advanced manufacturing technologies designation program and announced the establishment of a new advisory committee on genetic metabolic diseases. Read More
The FDA has released a revised Manual of Policies and Procedures (MAPP) on ANDA labeling revisions to reflect certain changes mandated by lawmakers late last year. Read More
Manufacturers of 48 Medicare Part B drugs raised their prices faster than inflation in the last quarter of 2023 — in some cases even in each quarter over the past year — and the drugmakers will now face stiff penalties under the year-old Inflation Reduction Act (IRA), the White House said. Read More
An uptick in drug prices contributed to an increase of 8.4 percent in retail prescription drug spending in 2022, according to a recent CMS report. Read More