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It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care The Big Story Senate panel clears ...
Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...
The FDA is urging customers with a milk allergy to avoid consuming the recalled chocolate products. Customers can also return the products to where they were purchased for a full refund, according to ...
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...
A coalition of ALS patients and caregivers is petitioning the FDA to review available data on the stem cell therapy NurOwn ...
The Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in a Complete Response Letter (CRL) for etripamil nasal spray (Cardamyst ™ ), an investigational ...
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