CVS Health will separate into a healthcare solutions company and a standalone CVS Pharmacy by the first half of 2028. Who gets what, the Q3 numbers behind the move and what it means for patients and drugmakers.
The FDA has issued warning letters to two Chinese API makers that shipped ingredients for US compounding and refused records requests. What the letters say and why it matters.
BIO and two California biotech groups have sued to block Medicare’s GLOBE model, which ties Part B drug rebates to prices in 19 countries from 2027.
Compass Pathways has completed its COMP360 psilocybin NDA for treatment-resistant depression. Here is the Phase 3 data, the voucher timeline and the DEA hurdle.
CVS Health will separate into a healthcare solutions company and a standalone CVS Pharmacy by the first half of 2028. Who gets what, the Q3 numbers behind the move and what it means for patients and drugmakers.
The FDA has issued warning letters to two Chinese API makers that shipped ingredients for US compounding and refused records requests. What the letters say and why it matters.
BIO and two California biotech groups have sued to block Medicare’s GLOBE model, which ties Part B drug rebates to prices in 19 countries from 2027.
Compass Pathways has completed its COMP360 psilocybin NDA for treatment-resistant depression. Here is the Phase 3 data, the voucher timeline and the DEA hurdle.
J&J’s Caplyta (lumateperone) beat placebo in Study 452, its second pivotal Phase 3 trial in bipolar I mania, clearing the way for an FDA filing. Here is how the two studies compare.
argenx will buy Unnatural Products for up to $1.15B ($550M upfront) to own an oral macrocyclic peptide platform. Terms, strategy, risks and market context.
FDA approves Pimjetmi (pimicotinib), a once-daily CSF-1R inhibitor for tenosynovial giant cell tumor, after a 54% vs 3% response in Phase 3 MANEUVER. How it stacks up.
FDA grants accelerated approval to subcutaneous amivantamab for recurrent or metastatic HNSCC after a 42% response rate in OrigAMI-4. Eligibility, data, safety and next steps.
Bayer’s Sunharbo (asundexian) is the first factor XIa inhibitor approved by the FDA. It cut ischemic stroke risk by 26% in 12,327 patients after a recent stroke or high-risk TIA.
