News

FDA issues risk warning after mushrooms recalled nationwide
The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed. Listeria monocytogenes can lead to severe and sometimes fatal infections, ...
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 ...
FDA approves shot that protects dogs from fleas and ticks for 8-12 months
The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...
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 ...
Weaver Nut Company chocolate recall under FDA's highest risk level
The FDA recalled some chocolate products by the Weaver Nut Company chocolate, warning about possible serious to ...
STAT2d
FDA publishes rejection letters sent to drugmakers, with a big caveat
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with ...
US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
Blockbuster long acting flea and tick treatment for dogs coming after FDA approval
A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the ...
BioPharma Dive2d
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 ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...
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 ...
Senate panel clears FDA appropriations
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...