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.
Latest — Page 20
Deals
Boston Scientific buys into MiRus for up to $4.5B
Boston Scientific paid $1.5B for 34% of MiRus and locked in a $3B option for its SIEGEL TAVR system, one year after scrapping its own valve program.
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.
Legal
Sued: Adani Executives Over $750M Bond Fraud
Adani Green sold $750M in bonds while its founder personally orchestrated bribe payments to Indian officials, the SEC alleged in late 2024.
SEC
CFPB Drops Disparate Impact in 3-Part ECOA Overhaul
CFPB just scrapped disparate impact under ECOA, but mortgage lenders and state AGs in New York, New Jersey, and Massachusetts won't play along.
Legal
Polis Cuts Peters' 9-Year Election Data Sentence
Judge Barrett called Peters a 'charlatan' who'd do it again. Colorado's governor cut her 9-year sentence anyway, after just 18 months.
Legal
Defies EO 14281: NYDFS Keeps NY Disparate Impact Rule
NYDFS is telling NY lenders that disparate impact still applies, directly contradicting Trump's EO 14281 and the CFPB's Regulation B rewrite.
Legal
Ruled: Jules Seals Section 3 FAA Stay Jurisdiction
Jules v. Balazs locks federal courts onto post-arbitration jurisdiction for stayed FAA cases, closing the Badgerow gap businesses feared.
Legal
Poisoned node-ipc Steals 690K Devs' Credentials
Three malicious node-ipc versions drain cloud keys, SSH creds, and CI/CD tokens via DNS; attacker hijacked an inactive npm maintainer's account.
AI
Hacked for $65K: Cursor, Codex at Pwn2Own Berlin
Three AI coding agents fell at Pwn2Own Berlin for $65K in prizes, and the patch window for Cursor and Codex won't close for 90 days.
SEC
Ran First: SVB's $49M Depositors Led 2023 Bank Runs
FDIC's transaction-level data shows the $49M-threshold depositors who drained SVB in six days, and they ran at Signature and First Republic too.
Legal
Reqrea Exposed 1M Hotel Passports Without Password
Japanese startup Reqrea left 1 million hotel passports in a public S3 bucket anyone could read. Its investigation has no published timeline.
AI
Robbed $600M: AI Suspected in Drift, Kelp DAO Hacks
Drift and Kelp DAO lost nearly $600M in April. Cybersecurity experts now say the speed of those attacks is consistent with AI assistance.
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.
