FDA
Sanofi Cuts Riliprubart Phase 3 Over Efficacy Miss
Sanofi pulled the MOBILIZE phase 3 after an independent DMC found riliprubart unlikely to deliver, leaving $555M in projected CIDP sales at risk.
FDA — Page 3
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
Novo Fires Back as Lilly's Retatrutide Hits 30%
Lilly's retatrutide hits 30.3% weight loss at two years while Novo Nordisk's oral Wegovy crosses 3 million scripts and queues two H2 FDA decisions.
FDA
FDA Built 3 Rare Disease Routes; Key Rules Unclear
Three new FDA pathways promise faster rare disease approvals, but open questions on exclusivity could blunt their commercial impact.
FDA
Lilly Drops 28.3% Weight Loss, 73% Knee Pain Cut at ADA
Retatrutide cuts knee pain 73% and sleep apnea 60% at ADA: the multi-indication Phase 3 data that could reframe GLP-1 regulatory strategy.
FDA
Roche Paid $1.65B for Petrelintide's Phase 2 GI Data
Roche put $1.65B behind petrelintide's amylin mechanism. New ZUPREME-1 data from ADA 2026 shows just how clean the GI profile actually is.
FDA
Roche Bets on 9% Weight Loss as Obesity Sweet Spot
Roche and Zealand say 9% weight loss with placebo-like tolerability beats 20% if patients can't stay on the drug. Phase 3 starts H2 2026.
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
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.
