Governmental or Regulatory Activity – Page 6

FDA Flags Concerns Over Intercept’s Ocaliva Approval in Advisory Committee Briefing

7 months ago talkbio0Tagged Advisory Committees, Biliary Cholangitis, Intercept Substance, Liver diseases, Ocaliva, United States Food and Drug Administration

Ocaliva, Intercept Pharmaceuticals, FDA, Advisory Committee, Primary Biliary Cholangitis, Liver Disease

BIOSECURE Act Clears House Hurdle, Heads to Senate for Vote on Restricting Chinese Biotech Ties

8 months ago talkbio0Tagged BIOSECURE, Biotech Companies, Biotechnology, Chinese Language, Drug Industry, drug supply chain, innovation, National Security, Risk, Senate, United States, US House of Representatives, Voting

BIOSECURE Act, House of Representatives, Senate Vote, Chinese Biotech Companies, National Security Risks, U.S. Pharmaceutical Industry, Biotechnology Innovation, Drug Supply Chain

Key Democrat to Oppose Biosecure Act, Citing Concerns Over Legislation’s Design and Impact on U.S.-China Biotech Relations

8 months ago talkbio0Tagged BGI, Biological Factors, Biosecure Act, Congressional opposition, National Security, Relations, restrictions, U.S.-China, WuXi

Biosecure Act, U.S.-China relations, biotech restrictions, national security, WuXi Biologics, BGI, Congressional opposition

FDA Raises Concerns Over Inappropriate Use of Iterum’s Antibiotic Ahead of Advisory Committee Meeting

8 months ago talkbio0Tagged Advisory Committees, Antibiotic Resistance, Microbial, etzadroxil/probenecid, Iterum, sulopenem, United States Food and Drug Administration, Urinary tract infection, uUTIs

Iterum Therapeutics, FDA, antibiotic resistance, sulopenem etzadroxil/probenecid, uncomplicated urinary tract infections (uUTIs), advisory committee meeting

FDA to Reassess Checkpoint Inhibitors for Stomach Cancer Based on PD-L1 Expression

8 months ago talkbio0Tagged Advisory Committees, checkpoint inhibitors, Gene Expression, Oncologic, PD-L1, United States Food and Drug Administration

FDA, checkpoint inhibitors, stomach cancer, PD-L1 expression, Oncologic Drugs Advisory Committee

Embracing Agility: Critical for the Role of QARA Professional

8 months ago talkbio0Tagged Access, Agility, AI, Artificial Intelligence, Communication, Diversity, Inclusion, Leadership, Market, professional occupation status, QARA, quality assurance, Regulatory Affairs, regulatory strategy, Technology

QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.