Advice – Talk Bio

FDA may not renew Pfizer’s pediatric COVID-19 shot authorization, creating uncertainty for fall child vaccinations

1 week ago talkbio0Tagged Advice, authorization, Centers for Disease Control and Prevention (U.S.), Child, Comparison, COVID19 (disease), EUA, Eua (gastropod), Moderna, Pediatric brand name, Pfizer-BioNTech, Regulatory Framework, renewal, United States Food and Drug Administration, Vaccination, Vaccines

FDA; Pfizer-BioNTech; pediatric COVID-19 vaccine; EUA renewal; authorization not renewed; child vaccinations; fall 2025; regulatory framework; Moderna comparison; CDC guidance

AbbVie Raises 2025 Guidance and Eyes Strategic Deals in Neuroscience, Obesity, and Oncology

3 weeks ago talkbio0Tagged AbbVie, Advice, earnings, Neuroscience discipline, Obesity, PD-1/VEGF, Strategic Deals

AbbVie; 2025 guidance; earnings; neuroscience; obesity; PD-1/VEGF; strategic deals; pharmaceuticals

Eli Lilly’s Zepbound Surpasses $4.9 Billion in First Year Sales Despite Q4 Shortfall

7 months ago talkbio0Tagged Advice, earnings, Eli, Eli Lilly, Glucagon-Like Peptide 1, Mounjaro, Obesity, pharmaceutical revenue, Zepbound

Eli Lilly, Zepbound, obesity drug, Q4 2024 earnings, pharmaceutical revenue, GLP-1 medications, Mounjaro, 2025 guidance

Pfizer Exceeds Q4 Expectations: COVID-19 Products and Cost-Cutting Drive Strong Performance

7 months ago talkbio0Tagged Advice, cost-cutting initiatives, COVID19 (disease), earnings, financial recovery, Pfizer, portfolio, revenue growth

Pfizer, Q4 earnings, COVID-19 portfolio, cost-cutting initiatives, revenue growth, Paxlovid, financial recovery, 2025 guidance

FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025

8 months ago talkbio0Tagged Advice, Aortic Valve Insufficiency, Artificial Intelligence, Drug Approval, Drug Development, Medical Devices, regulatory decision-making, United States Food and Drug Administration

FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development

Gilead Sciences Surpasses Q3 Earnings and Sales Forecasts, Boosts Annual Outlook

10 months ago talkbio0Tagged Advice, annual, Biktarvy, earnings, Gilead Sciences, HIV, HIV Prevention, Lenacapavir, Veklury

Gilead Sciences, Q3 earnings, HIV drug sales, annual guidance, Biktarvy, Veklury, lenacapavir, HIV prevention

Bristol Myers Squibb Posts Strong Q3 Results, Boosts 2024 Guidance on Robust Sales of Legacy and New Drugs

10 months ago talkbio0Tagged Advice, Drug Industry, earnings, financial performance, Inheritance, Myers, squibb

Bristol Myers Squibb, Q3 earnings, 2024 guidance, legacy drugs, newer drugs, pharmaceutical industry, financial performance

Merck Reports Strong Q3 Results but Lowers Full-Year Sales Guidance

10 months ago talkbio0Tagged Advice, Capvaxive, full-year, Gardasil, Januvia, Keytruda, Merck, results, Sales - occupational activity, Winrevair

Merck, Q3 Results, Full-Year Sales Guidance, Keytruda, Gardasil, Januvia, Winrevair, Capvaxive

AI Guidance for Investors: Navigating the Future with Strategic Approaches and Regulatory Insights

11 months ago talkbio0Tagged Adoption, Advice, Artificial Intelligence, Computer Security, governance, Health care facility, investors, Mapping Strategies, Regulatory Impact, Risk, Strategic AI

AI Guidance for Investors, Strategic AI Adoption, Regulatory Impact on AI, Cybersecurity Risks in AI, AI Mapping Strategies, Data Governance in AI, Future of AI in Healthcare

FDA Updates Guidance to Combat Online Misinformation About Medical Products

11 months ago talkbio0Tagged Advice, Clarity, medical products, online misinformation, public health medicine (field), regulatory, United States Food and Drug Administration

FDA, online misinformation, medical products, guidance, regulatory clarity, public health