Amneal Pharmaceuticals Gets FDA Approval for Alzheimer's Treatment and Brain Tumor Drug
Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a dementia treatment and a drug targeting certain types of brain tumors, as well as tentative approval for a drug ...
FierceBiotech1h
FDA delays decision on Stealth's 2nd shot at approval for ultrarare disease med
An FDA advisory committee may have ruled in elamipretide’s favor back in October, but it looks like Stealth BioTherapeutics ...
Managed Healthcare Executive2d
FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or ...
The FDA is about to make weight-loss drugs a lot harder to get
Lots of people are on cheaper compounded weight-loss drugs that mimic brands like Ozempic, Wegovy, and Zepbound. They're ...
Pharmaceutical Technology2h
Disc raises $225.5m as it eyes approval of rare skin disorder drug
Disc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA ...
FDA bans Red 3 dye from food and drugs – a scientist explains the artificial color’s health risks and long history
However, mounting scientific evidence suggests that consuming Red 3 poses significant health risks. These risks prompted California to ban its use in food in 2023 and the Food and Drug Administration ...
FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases
Teva Pharmaceutical’s Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that ...
The Dangers Hidden In CMS’ Drug Pricing Regulation
The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to ...