1️⃣ FDA is squeezing GLP-1 compounders again
FDA proposed on April 30 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list after finding no clinical need for outsourcing facilities to compound them from bulk substances.
Why it matters
This pushes GLP-1 supply back toward approved manufacturers unless a shortage creates another legal opening. Novo and Lilly get cleaner channel control; compounders get less room to scale.
Coffee talk
If shortages are no longer the excuse, what exactly is left for high-volume GLP-1 compounding?
2️⃣ Camizestrant just hit the ctDNA bar
FDA’s ODAC voted 6 to 3 against AstraZeneca’s camizestrant NDA for switching HR+/HER2- metastatic breast cancer patients with emerging ESR1 mutations before radiographic progression.
Why it matters
The panel did not reject oral SERDs. It pushed back on changing first-line treatment early on ctDNA surveillance without enough clinical benefit.
Coffee talk
If ctDNA sees resistance first, how much proof does FDA still want before doctors are told to move?
3️⃣ Auvelity gets a second CNS launch
FDA approved Auvelity for agitation associated with dementia due to Alzheimer’s disease in adults, making it the first approved non-antipsychotic treatment for the condition.
Why it matters
Axsome now has a label that moves Auvelity beyond depression and into a hard neuropsychiatry market. The next test is access, not FDA timing.
Coffee talk
If it avoids the antipsychotic baggage, how fast do payers let doctors change habit?