All updates
All updates
today 30中文产业新闻Chinese source评分6363 中文产业新闻精选Chinese source评分6060 爱德华 EVOQUE 经导管三尖瓣置换系统获中国特殊准入并在阜外医院完成首批临床应用
中文产业新闻精选Chinese source评分6868 FDA批准艾伯维JUVMO治疗帕金森病
中文产业新闻Chinese source评分6262 艾伯维D1/D5受体部分激动剂tavapadon获FDA批准用于帕金森病
Endpoints News评分88 New biotech alliance tells Congress to fight for US dominance
Endpoints News评分2424 CMS finalizes GLOBE Medicare demo, but savings trail projections
STAT News评分4545 STAT+: HHS announces new efforts to speed up, expand clinical trials with AI
STAT News评分3030 STAT+: Trump’s watered-down Medicare drug pricing rule saves 96% less than initial proposal
FDA Drugs评分1010 Advancing Generic Drug Development: Translating Science to Approval 2025 - 10/07/2025
FDA Drugs精选评分6363 Fresenius Kabi USA LLC - 733107 - 09/22/2026
FDA Drugs评分2525 Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) - 09/17/2026
FDA Drugs评分3232 Biosimilars Action Plan
FDA Drugs评分55 Registered Outsourcing Facilities
FDA Drugs精选评分6161 FDA approves first drug to improve functional capacity and symptoms in children with rare inherited heart condition
FDA Drugs评分1717 Notable Approvals | Drugs
FDA Drugs评分1111 FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates - 09/29/2026
FDA Drugs评分55 CDER Small Business & Industry Assistance (SBIA)
FDA Drugs评分1818 E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
FDA Drugs评分2121 FDA Adverse Event Monitoring System (AEMS) – E2B(R3) Data Standards
FDA Drugs精选评分4646 FDA Adverse Event Monitoring System (AEMS) Electronic Submissions
监管与产业动态评分3232 FDA hits 2nd Fresenius site with contamination-related warning letter in less than a month - Fierce Pharma
监管与产业动态评分1717 Two charged in scheme to sell counterfeit Ozempic—how you can spot fake meds
STAT News评分3434 U.S. poised to boot legal immigrants from Medicaid, including refugees and sex-trafficking victims
BioPharma Dive精选评分5050 FDA starts review of Roche’s multiple sclerosis pill
FDA Press Releases评分2222 FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
FDA Drugs评分2121 New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
FDA Drugs评分22 What's New Related to Drugs
FDA Drugs评分3030 April - June 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
监管与产业动态评分1919 Vanda lines up new expansion prospect for Hetlioz as FDA jet lag hearing looms - Fierce Pharma
BioSpace评分4545 Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
监管与产业动态评分1616 VertigoDx on firm ground with FDA greenlight for vertigo diagnostic system - Fierce Biotech
EMA News评分2727 Women are missing from medicines development: EMA’s roadmap for change
STAT News评分1717 Kratom and 7-OH should be regulated, experts agree. They’re split on how
STAT News评分3333 STAT+: Lawmakers urge Trump to rethink new rule that could restrict imported meds from Canada and overseas
FDA Drugs评分2323 FDA/Center for Research on Complex Generics (CRCG) Workshop on Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment - 12/01/2026
FDA Drugs评分2828 The Center for Research on Complex Generics
FDA Drugs评分2222 Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
FDA Drugs评分2424 FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
FDA Drugs评分1212 CDER Patient-Focused Drug Development
监管与产业动态评分99 Canadian $5M accelerated clinical trial program cuts start-up to 45 days - Fierce Biotech