Business Wire

Sesh Products US Inc.'s Nicotine Pouch Bundled PMTA Advances to FDA Substantive Scientific Review Phase

Application Covering 64 SKUs Clears FDA Filing Review, Poised to Enter the Final Regulatory Phase Prior to a Marketing Order Decision AUSTIN, Texas--(BUSINESS WIRE)--Sesh Products US, Inc. (Sesh) ...
Healthline

FDA Doesn’t Endorse Leucovorin for Autism, OKs It for Rare Brain Disorder

Share on Pinterest More research is still needed before leucovorin should be approved as an autism treatment. Westend61/Getty Images Federal regulators have approved leucovorin for the treatment of ...
Scientific American

FDA declines to approve drug touted by Trump as a treatment for autism

The FDA on Tuesday approved leucovorin as a treatment for a rare genetic condition, not for autism, as the Trump administration had suggested The U.S. Food and Drug Administration on Tuesday approved ...
Disability Scoop

FDA Widens Approval Of Drug Hyped For Autism

Months after Trump administration officials promoted a medication as a possible treatment for autism, the Food and Drug Administration is expanding the drug’s approval, but not for everyone with the ...
FiercePharma

FDA approves leucovorin for ultrarare cerebral folate deficiency subset without clinical trial

About five months after U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. touted leucovorin as “an exciting therapy that may benefit large numbers of children who suffer ...
Medscape

FDA Approves New Drug Combo for RR Multiple Myeloma

The FDA has approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for the treatment of certain adult ...
CNBC

FDA official calls UniQure's gene therapy a 'failed' treatment for Huntington's disease

UniQure needs to run another study to prove its gene therapy "actually helps people with Huntington's disease," a senior FDA official said. The official said UniQure is the "latest company to make a ...
CNN

FDA goes on offense amid surge of criticism for recent drug decisions

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...
RAPS

FDA drafts guidance explaining 3-year clinical investigation exclusivity for new drugs

In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...
Bloomberg L.P.

FDA to Give Staff Bonuses for Speeding Up Drug Reviews

The US Food and Drug Administration plans to give bonuses to scientific staff for speeding up drug reviews, according to an FDA official familiar with the matter. The initiative will give staff ...
FierceBiotech

FDA accepts filing for Moderna flu vaccine after swift rethink

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...