News

FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
US FDA declines to approve Ultragenyx's gene therapy for rare inherited disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
FDA Issues Risk Warning for Sunscreen Recall in Multiple States
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...
Senate panel clears FDA appropriations
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...
FDA fully approves Moderna's COVID vaccine for some young kids
Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...
Recall alert: FDA warns against eating these chocolate products
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 ...
STAT10h
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
BioPharma Dive1d
FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
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Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...
ALS News Today10h
Advocates ask for new FDA review of stem cell therapy NurOwn
A coalition of ALS patients and caregivers is petitioning the FDA to review available data on the stem cell therapy NurOwn ...
MPR5h
PSVT Treatment Etripamil Nasal Spray Gets Another FDA Review
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 ...