FDA
Hits 30% weight loss: Lilly triple-G surfaces cardiac signal
Retatrutide's 30.3% weight loss at 104 weeks rivals bariatric surgery, but seven arrhythmias in Transcend-T2D-1 complicate Lilly's NDA path.
FDA — Page 2
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
Paid $10B, Pfizer Gets Berobenatide 15.9% Obesity Data
Pfizer's berobenatide posted 15.9% weight loss at 32 weeks with no plateau, its first ADA showing since the $10B Metsera deal closed.
FDA
FDA Hits Medline Drug Plant Over 9 Contamination Events
Medline's $6.3B IPO didn't shield it from two FDA warning letters, the second citing nine contamination events at its Illinois plant.
FDA
Paid $1.2B for IBI363, Takeda Gets 47% 2-Year Survival
IBI363's phase 1 data put 47% of IO-resistant NSCLC patients alive at 24 months, the first real test of Takeda's $11.4B Innovent bet.
FDA
Akeso Ivonescimab Cuts Death Risk 34% in Squamous NSCLC
Ivonescimab posted HR 0.66 and a four-month survival edge in HARMONi-6; Summit now needs its global HARMONi-3 data to deliver the same.
FDA
Cuts Metastasis Risk 20%: J&J's Erleada Targets Surgery
J&J's Proteus phase 3 shows Erleada cut metastasis risk 20% and nearly doubled time before additional therapy, from 3.5 to 6-plus years.
FDA
Ivonescimab Cuts NSCLC Death Risk 34% in Phase 3
Ivonescimab's 34% OS win over PD-1 chemo in squamous NSCLC is a phase 3 first, but the trial excluded patients over 75 and enrolled almost no women.
FDA
Cuts DLBCL Risk 25%: Monjuvi Takes On Polivy
Incyte's phase 3 frontMIND data cuts DLBCL progression risk 25%, but seven drugs and a pending OS read leave the first-line market wide open.
FDA
Pfizer Cuts J&J's mCSPC Lead With 52% PFS Win
Talapro-3's 52% rPFS reduction spans both BRCA and non-BRCA HRR alterations, the full-spectrum breadth J&J's Akeega couldn't earn from FDA.
FDA
Summit's Ivonescimab OS Data Could Shake NSCLC Billions
Ivonescimab's HARMONi-6 OS data hits ASCO's plenary Sunday, with AbbVie, BioNTech, and Merck holding competing bets on who wins the PD-1/VEGF race.
FDA
FDA Warns Alchymars Again: Eight Years, Same Gaskets
FDA's second warning to Alchymars in eight years cites the same deteriorated equipment FDA cleared in 2023, plus an import alert on top.
FDA
FDA's First AI Warning Letter Hits Purolea Lab
A Michigan drug maker let AI write its specs and skipped validation. The FDA just made it the first cGMP enforcement case naming AI misuse.
FDA
How to Respond to an FDA Form 483 in 15 Days
The FDA's first 483-response guidance sets a 15-day clock and wants risk assessments. Miss the window and you invite a warning letter.
FDA
Form 483 vs Warning Letter: What's the Difference
One is field notes from an FDA inspector. The other is the agency's formal legal escalation. Confuse them and you mishandle both.
FDA
Hit 13.2-Month OS: Revolution, Summit Eye ASCO Plenary
Revolution Medicines nearly doubled survival in pancreatic cancer with daraxonrasib. ASCO 2026's plenary will surface the toxicity data.
FDA
Racing to FDA: Dyne, REGENXBIO Lead 5 DMD Submissions
Five DMD programs are targeting FDA submissions in 2026, but two safety signals at REGENXBIO may set the bar that clears or kills the wave.
FDA
Ousted: RFK Jr. Ends Makary's 13-Month FDA Tenure
Makary's 13 months at the FDA ended May 12 over a flavored-vape standoff, with food deputy Kyle Diamantas now acting commissioner.
FDA
CHMP Backs Camizestrant After ODAC's 3-6 No Vote
CHMP backed camizestrant for ER+/HER2- breast cancer as ODAC voted 3-6 against. Europe and the US disagree on trial design, not the drug's efficacy.
FDA
Gilead Wins Hepcludex Nod Four Years After FDA Rejection
Gilead's Hepcludex wins US approval four years after a manufacturing CRL, becoming the first treatment for HDV in a market of up to 80,000 patients.
FDA
FDA Clears Datroway First-Line TNBC
FDA cleared Datroway May 22 for first-line metastatic TNBC, backed by a $1B upfront AZ bet and a $5B peak sales target, first to beat chemo on OS.
