FDA Will Issue Drug Approval Decisions This Week

Regulators reach key deadlines for Egetis Therapeutics and Bristol Myers Squibb by the end of September.

Updated on Sept. 28, 2026 in Biotech

Bold flat-color editorial illustration of two pharmaceutical vials, symbolic of the rigorous FDA drug approval review process. — The FDA faces critical review deadlines this week for new drug applications from Egetis Therapeutics and Bristol Myers Squibb. AI Illustration. Upload story photo >

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The FDA faces upcoming regulatory deadlines on September 28 and September 30 for two separate drug applications. These decisions follow recent approvals granted to Scholar Rock, Biofrontera, and Mirum Pharmaceuticals earlier this month.

Why it matters

These PDUFA dates represent the final target deadlines for the FDA to conclude its review process for new drug applications or label expansions. The outcomes will determine market access for specialized treatments in the United States.

The FDA is evaluating Egetis Therapeutics' Emcitate and a label expansion for Bristol Myers Squibb's Camzyos. Camzyos is currently approved for specific symptomatic adults, while Emcitate is already authorized for use within the European Union.

The players

Bristol Myers Squibb

A global pharmaceutical company focused on developing therapies for cardiovascular and oncological conditions.

Egetis Therapeutics

A Stockholm-based clinical-stage company specializing in therapies for rare and orphan diseases.

Mirum Pharmaceuticals

A biotechnology firm focused on developing and commercializing therapies for liver and other rare diseases.

Scholar Rock

A clinical-stage biopharmaceutical company focused on protein growth factor therapies.

Biofrontera

A biopharmaceutical company specializing in dermatological drugs and medical devices.

The details

The Food and Drug Administration utilizes PDUFA dates—Prescription Drug User Fee Act deadlines—to structure the timeline for reviewing new drug applications. The pending review for Bristol Myers Squibb concerns the expansion of Camzyos, a treatment currently indicated for adults with symptomatic obstructive hypertrophic cardiomyopathy, a condition where the heart muscle thickens. Egetis Therapeutics is awaiting a decision on Emcitate, which is already approved for use in the European Union.

September 25, 2026: The FDA approved Mirum Pharmaceuticals' Atebrioz.
September 28, 2026: The FDA deadline for Egetis Therapeutics' Emcitate.
September 30, 2026: The FDA deadline for Bristol Myers Squibb's Camzyos.

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The Tech Race

These regulatory milestones operate under the established timelines of the Prescription Drug User Fee Act. Companies are currently managing these decision dates alongside broader market performance, with year-to-date share gains reaching as high as 63% for firms like Biofrontera.

The availability of these treatments depends on these upcoming FDA decisions. Following approval, therapies like Atebrioz are slated for US rollout as soon as next month, contingent on the final regulatory outcome.

The takeaway

The FDA will conclude its review of Emcitate and the Camzyos expansion by the end of this week. Investors and patients should monitor the FDA's public database for final approval announcements scheduled for September 28 and September 30.