Super Bowl ad for Hims & Hers' weight loss drug sparks backlash
The ad goes on to tout Hims & Hers' weight loss drugs as less expensive alternatives to medications like Ozempic and Wegovy, ...
Food Allergy Research & Education11 天
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 ...
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® ...
360dx6 小时
LetsGetChecked Lancing Device Nabs FDA 510(k) Clearance
Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single-use blood ...
manilatimes12 小时
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 ...
BioSpace6 天
SpringWorks Wins FDA Nod for Neurofibromatosis Drug, Tees Up Challenge to AstraZeneca
The FDA on Tuesday signed off on SpringWorks Therapeutics’ mirdametinib—now to carry the brand name Gomekli—for the treatment ...
Crain's Chicago Business11 天
AbbVie gets FDA OK on antibiotic therapy that fights resistant bacteria
It's the first and only such therapy approved to fight antimicrobial resistance, or AMR, in bacterial infections.
Over 89,000 Bottles of Nasal Spray Recalled By FDA—What to Know
There’s another recall to be aware of right now, and it involves nose spray. NeilMed Pharmaceuticals Inc., the manufacturer of NasoGel Spray, has issued an international recall of 89,312 of its sprays ...