News

FDA warns against dangerous ‘gas station heroin’ drug
The unapproved antidepressant is sold in gas stations and online under various names, leading to addiction and severe side ...
PharmExec3d
FDA Grants Accelerated Approval to Verastem Oncology’s Avmapki Fakzynja Co-Pack for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer
The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade ...
Food Safety News7h
FDA says approval of 3 food dyes will help companies voluntarily switch to natural substances
As part of its attempt to force food companies to voluntarily stop using artificial food dyes, the FDA has approved three dyes that it says come from ...
Fierce Pharma4d
FDA misses another approval decision target date, this time for GSK's Nucala in COPD
In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet ...
Cytokinetics: Strong Buy As FDA's 3-Month Delay Doesn't Derail Aficamten's Approval Outlook
The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop ...
dvm3603d
FDA approves Mometamax Single
The latest canine otitis externa medication is the only FDA-approved, 1-dose, in-clinic treatment for Pseudomonas aeruginosa ...
FDA says ‘dangerous’ substance known as ‘gas station heroin’ poses major risk to young people
FDA Commissioner Martin Makary sounded the alarm on tianeptine, also known as "gas station heroin," and its growing adverse ...
FDA issues warning against tianeptine use, also called 'gas station heroin'
The FDA is warning the public about a drug rising in popularity commonly referred to as as "gas station heroin." ...
Targeted Oncology4d
Avutometinib Plus Defactinib Gains FDA Approval in KRAS+ Ovarian Cancer
Avutometinib given with defactinib is now approved for the treatment of adult patients with recurrent low-grade serous, ...
FDA approves at-home pap smear alternative device for cervical cancer screening
The Food and Drug Administration has approved a new device called the Teal Wand, which its creator describes as an "at-home ...
Health Affairs15h
In Price Negotiations, Medicare Should Reassess How It Determines A ‘Qualifying Single Source Drug’
Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...
Food Safety News4d
FDA delays implementation of rule that would require new nutrition labeling
The FDA is delaying implementation of a rule that would require food companies to print nutritional information on the front labels of their products. The ...