Governmental or Regulatory Activity
Key Democrat to Oppose Biosecure Act, Citing Concerns Over Legislation’s Design and Impact on U.S.-China Biotech Relations
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
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
FDA, checkpoint inhibitors, stomach cancer, PD-L1 expression, Oncologic Drugs Advisory Committee
Embracing Agility: Critical for the Role of QARA Professional
QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.
Biden Administration Announces Historic Lower Drug Prices for Medicare Beneficiaries
Biden Administration, Medicare, Drug Prices, Inflation Reduction Act, Prescription Drug Costs
Landmark Medicare Negotiations Set Prices for 10 Key Drugs, Projecting Billions in Savings
Medicare, drug prices, Biden administration, pharmaceutical companies, Inflation Reduction Act, prescription drugs, seniors, healthcare costs
Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September
Alfasigma, Ocaliva, PBC, FDA advisory committee, primary biliary cholangitis, liver disease treatment
Actinium’s Radioconjugate Faces Setback as FDA Requests New Study
Actinium Pharmaceuticals, radioconjugate, FDA, new study, Iomab-B, regulatory affairs, biotech, cancer treatment
FDA Advisors Back Zevra’s Rare Disease Medication Based on Clinical Intuition
Zevra Therapeutics, FDA advisory committee, rare disease medication, clinical intuition, potential approval
FDA Advisory Committee Approves Zevra Therapeutics’ Arimoclomol for Rare Genetic Disease Treatment
Zevra Therapeutics, Arimoclomol, FDA Advisory Committee, Niemann-Pick disease, rare genetic disease, drug approval