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 — Page 4
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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.
FDA
Ousted: Biohaven Ran the Campaign Against Makary
Biohaven's CEO and other biotech leaders quietly lobbied the White House to push out FDA's Makary after troriluzole's November CRL.
FDA
Bimzelx Beats Skyrizi 49% to 38% on ACR50 in PsA Trial
BE BOLD's Phase 3 data put a 10-point ACR50 gap between Bimzelx and Skyrizi, the $17.56B drug AbbVie built its post-Humira franchise on.
FDA
Resigned: Makary, Four FDA Leaders Out in a Week
Makary's exit triggered a cascade: four more FDA leaders gone in a week, and biotech wants Richard Pazdur next. The White House hasn't said yes.
FDA
Paid $1.4B for Sac-TMT, Merck Gets Phase 3 Win
A $1.4B Kelun bet pays off: Merck's sac-TMT is first in a global Phase 3 to beat chemo on OS and PFS in post-platinum endometrial cancer.
FDA
FDA Cleared Lilly Foundayo in $9.3B Obesity Race
Lilly cleared Foundayo on April 1, but the label carries a required post-market trial for four serious risks, including MACE and liver injury.
FDA
FDA Clears AstraZeneca's Baxfendy, $5B Peak Sales
AstraZeneca's $1.3B CinCor buy paid off: FDA cleared Baxfendy, first-in-class for hypertension, with Leerink's $10B upside scenario on the table.
FDA
FDA Alleges Fraud as Tavneos Deaths Hit 20 in Japan
A $3.7 billion drug acquisition is unraveling: 20 deaths, a market withdrawal demand, and now FDA allegations of manipulated trial data.
FDA
FDA cleared Enhertu twice: early breast cancer, $5.4B
Enhertu's $5.4B annual sales projection grows with dual early breast cancer clearance, but patients who used it before surgery can't get it after.
FDA
Paid $270M for BMN 401, BioMarin Misses Phase 3
BioMarin's $270M Inozyme bet just got complicated: BMN 401 hit the biomarker endpoint but missed skeletal healing and all secondary goals.
FDA
CDER Chief Høeg Exits in FDA Leadership Shake-Up
When FDA's CDER chief exits and other senior roles turn over at once, pharma has a genuine question: who's running the review process.
FDA
Recalled: Glass Found in 675 Sun Pharma Chemo Vials
Glass particles in 675 Sun Pharma cancer drug vials could trigger blood clots. The Indian plant making them has 10 years of FDA violations.
FDA
FDA Freezes Aardvark ARD-101 Trial, Stock Down 30%
FDA's full clinical hold on ARD-101 sent Aardvark down 30%, and two analyst firms warn the cardiac signal may cap what safe doses can do.
FDA
Encoded Gene Therapy Cuts Dravet Seizures 76%
Encoded's gene therapy hit 76% seizure reduction in Dravet syndrome kids. Trial details are sparse and no regulatory path has been announced.
FDA
FDA Clears BeOne's Beqalzi as First BCL-2 for MCL
BeOne's Beqalzi won the first U.S. BCL-2 approval specifically for mantle cell lymphoma, with CLL giant Venclexta squarely in its sights.
