The evaluation committee considered evidence submitted by Pfizer, a review of this submission by the external assessment group (EAG), and responses from stakeholders. See the committee papers for full ...

Compared with placebo, the drug tafamidis (Pfizer) reduces decline in left ventricular (LV) systolic and diastolic function, suggests post hoc analysis of a randomized trial of patients with ...

With backing from an FDA advisory committee and results from a positive phase 3 trial, respectively, Alnylam and BridgeBio are each on track to enter the blockbuster transthyretin amyloidosis ...

MUNICH, Germany—A new therapy offers a better chance at survival and improved symptoms for adults affected with transthyretin amyloid cardiomyopathy, a disease that previously had no good treatment ...

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Pfizer gambled big when it took data from a single study to back its application for tafamidis as a treatment for a rare neurodegenerative disease. And an FDA review of the data concludes decisively ...

The US Food and Drug Administration has approved two oral formulations of tafamidis—Vyndaqel and Vyndamax (Pfizer)—for the treatment of cardiomyopathy caused by transthyretin mediated amyloidosis.

Approval Represents a Major Advance, as Vyndaqel is the First and Only Medication Currently Approved to Delay Peripheral Neurologic Impairment in Stage 1 TTR-FAP Patients Vyndaqel(R) (tafamidis) is ...

(HealthDay)—In patients with transthyretin amyloid cardiomyopathy, treatment with tafamidis reduces all-cause mortality and cardiovascular-related hospitalizations versus placebo, according to a study ...

Pfizer Inc. PFE has been granted with fast track status by FDA for treating patients with transthyretin cardiomyopathy (TTR-CM). This rare disease is associated with progressive heart failure and is ...

Pfizer Inc. (PFE) has updated a Phase 1 study that looked at two oral forms of tafamidis in healthy adults under fed conditions. The official aim was to see if a new tafamidis free acid tablet matches ...