FDA
FDA Clears Arvinas' Veppanu, First PROTAC Drug
FDA cleared Veppanu (vepdegestrant) on Friday, a month ahead of its June 5 PDUFA date, making the Pfizer-Arvinas collaboration the first to take a PROTAC…
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Deals
Novartis Seals $23B US Build With NC API Plant
Novartis has committed $23 billion to build seven U.S. facilities, and the final piece just landed in Morrisville, North Carolina: a 56,200-square-foot…
FDA
FDA Approves Axsome's Auvelity for Alzheimer's Agitation
FDA approved Axsome Therapeutics' Auvelity for agitation in Alzheimer's disease patients.
FDA
Moderna Pushes FDA on Covid Vaccine Access with Post-Marketing Data
Moderna told FDA it will provide post-marketing data on its Covid-19 vaccines to restore access to a broader population, the company confirmed May 1.
AI
Restrict AI Agent Access: Six Agencies Warn
Six government cybersecurity agencies from the US, UK, Australia, Canada, and New Zealand just told every operator running agentic AI in production: your…
AI
Passed: Minnesota's Ban on AI Nude Apps
Minnesota's new nudification law applies to any company that makes AI tools capable of generating fake intimate images — and it targets the moment of…
SEC
CFPB Cuts Lender Data Rule: 2,500 to 280
$166 million in annual compliance savings sounds like a win.
Legal
SFO Secures Ultra Electronics DPA, £4.8M in Probe Costs
The UK Serious Fraud Office secured a court-approved Deferred Prosecution Agreement with Ultra Electronics Holdings Ltd, a British manufacturer of…
Legal
Tightens KYC, FCC Cuts 1999 Foreign Carrier Loophole
The FCC voted unanimously Wednesday to tighten Know Your Customer rules for U.S. telecoms, closing a loophole dating to 1999 that let foreign companies…
Legal
Cybersecurity Insiders Sentenced 4 Years for BlackCat Scheme
A federal court sentenced Ryan Clifford Goldberg, 40, a former Sygnia incident response manager, and Kevin Tyler Martin, 36, a former DigitalMint ransomware…
Deals
Bought: Sun Pharma's $11.75B Organon Deal
Sun Pharma paid $11.75 billion for Organon, the largest biopharma acquisition of 2026 and the biggest deal any Indian drugmaker has ever announced.
Legal
Jailed 4 Years: Sygnia, DigitalMint Ransomware Pair
DOJ sentenced two former cybersecurity professionals to four years each in federal prison Thursday for ransomware attacks they ran against U.S. companies in…
FDA
FDA Clears Auvelity for Alzheimer's, $2.1B Peak
FDA cleared Auvelity for agitation in patients with Alzheimer's dementia, making it the first non-antipsychotic drug cleared for this indication.
FDA
Fails CRC Trial: Krazati Approval at Risk for BMS
Bristol Myers Squibb's Krazati failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News.
FDA
FDA Panel Rejects AstraZeneca New Paradigm 6-3
FDA's oncology advisory committee voted 6-3 Thursday against AstraZeneca's late-stage trial for an oral drug candidate, voting down what the company had…
