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Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.
Fierce Pharma
Fierce Biotech
Fierce Healthcare
Fierce Life Sciences Events
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Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. | In this tracker, Fierce Pharma is recording the…

FDA accepts Sarepta's filings seeking traditional approval for AMONDYS 45 and VYONDYS 53, with a decision expected by February…

Modern drug development demands faster, more scalable gene expression insights. Download this white paper to explore how…

An independent research firm is reviewing data on Amgen’s Tavneos as the company prepares for a hearing later this month with the…

As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. | The program looks to support…