May 12, 2026

Makary Resigns as FDA Commissioner Following Policy Disputes

Transition follows disputes over vaccine policy, food additive regulation, and flavored vaping product authorization

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May 11, 2026

New Label Expansion in Generalized Myasthenia Gravis

Phase 3 ADAPT SERON data supported efgartigimod use across antibody subtypes often underrepresented in trials.

Conexiant

May 04, 2026

FDA Expands ASCENIV Pediatric Use

Label change follows completion of required pediatric evaluation and updates prior age restrictions for treatment eligibility.

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April 29, 2026

FDA Monthly Preview: Key May Decisions to Watch

Several FDA decisions across multiple specialties are expected this month.

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April 28, 2026

FDA Clears Breztri for Asthma Use

Single-inhaler triple therapy improved lung function vs dual therapy in phase 3 trials and showed rapid onset without new safety signals.

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April 02, 2026

CDC Lists Dozens of Infectious Disease Tests as Unavailable

More than two dozen assays paused or discontinued, with alternative testing options noted

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April 01, 2026

FDA Approves Lilly’s Foundayo Oral GLP-1 Pill

The newly approved therapy offers a noninjectable option that can be taken at any time of day without food or water restrictions.

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April 01, 2026

FDA Broadens CFTR Therapy Eligibility

The FDA expanded use of CFTR modulators to include more CF gene variants, increasing treatment eligibility across a wider US patient population.

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March 30, 2026

FDA Updates SMA Treatment Dosing

A higher-dose nusinersen regimen for spinal muscular atrophy demonstrated statistically significant motor function improvement in treatment-naïve infants in the DEVOTE trial with a safety profile consistent with prior dosing.

Conexiant

March 27, 2026

FDA Drops Age Limit for Neffy

Needle-free epinephrine expands access for younger children meeting weight criteria

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