FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
FDA approves tablet form of Evrysdi for spinal muscular atrophy
The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
US FDA approves GSK's combo meningococcal vaccine
The U.S. Food and Drug Administration approved British drugmaker GSK's combination vaccine to protect against meningococcal ...
Judge orders HHS, CDC and FDA to restore deleted webpages with health information
The NGO Doctors for America argued that HHS, CDC and FDA violated federal law in removing medical information from ...
Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes
Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® ...
Food Allergy Research & Education11d
Update to FDA Guidance for Food Allergen Labeling
Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...
FiercePharma6d
Roche scores FDA nod for Evrysdi tablets, bolstering convenience edge over rivals
Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...
manilatimes12h
Spectral AI Strengthens Financial Position Ahead of FDA Submission
"I am pleased to share this milestone as we continue advancing toward our FDA submission and work to bring our technology to ...
FDA Grants Fast-Track Designation To Cannabis Withdrawal Syndrome Drug
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...