research – Talk Bio

FDA names Tracy Beth Heg as acting CDER chief

1 month ago talkbio0Tagged CDER, Center for Drug Evaluation, Chief, COVID19 (disease), Drug Regulations, Leadership, research, Tracy Beth Heg, U.S. Food and Drug Administration, United States Food and Drug Administration, Vaccine Safety

Tracy Beth Heg; acting CDER chief; FDA leadership; Center for Drug Evaluation and Research; COVID-19 vaccine safety; drug regulation; U.S. Food and Drug Administration

Former FDA Chiefs Criticize Proposed Vaccine Policy Changes at ACIP Meeting

1 month ago talkbio0Tagged * New England Journal of Medicine*., ACIP, Centers for Disease Control and Prevention (U.S.), Changing, commissioners, COVID19 (disease), Policy, research, Senator Bill Cassidy, United States Food and Drug Administration, vaccine safety regulation, Vaccines, Vinay Prasad ; Center for Biologics Evaluation

former FDA commissioners; CDC; ACIP meeting; vaccine policy changes; COVID-19 vaccines; Vinay Prasad; Center for Biologics Evaluation and Research; vaccine safety regulation; Senator Bill Cassidy; New England Journal of Medicine commentary

Recent Developments on Vinay Prasad’s Leaked FDA Memo, Alzheimer’s Disease Updates, and Next-Gen Obesity Drugs

1 month ago talkbio0Tagged Alzheimer 's disease, Cessation of life, Child, COVID19 (disease), next-generation, Obesity, research, United States Food and Drug Administration, Vaccines, Vinay Prasad FDA memo

Vinay Prasad FDA memo; COVID-19 vaccine deaths children; FDA vaccine approval changes; Alzheimer’s disease research 2025; obesity drugs next generation; COVID-19 vaccine safety controversy; FDA vaccine policy overhaul

Top Drug Regulator Richard Pazdur to Retire from FDA Amid Industry Concerns

1 month ago talkbio0Tagged Center for Drug Evaluation, Drug Regulations, Leadership, Personnel Turnover, research, Retirement, Richard Pazdur, United States Food and Drug Administration

Richard Pazdur; FDA; retirement; Center for Drug Evaluation and Research; drug regulation; Marty Makary; leadership turnover

Rakovina Therapeutics Announces Q3 2025 Financial Results and Corporate Update

1 month ago talkbio0Tagged AI-powered, ATR Inhibitor, Clinical Nurse Specialists, Conferences, corporate milestones, development expenses, Ditiocarb, Drug Discovery, Eligibility Determination, financial results, Investments, NanoPalm joint-venture, net loss, Penetration, Q3, Rakovina, research

Rakovina Therapeutics; Q3 2025; financial results; net loss; research and development expenses; AI-powered drug discovery; ATR inhibitor; CNS penetration; corporate milestones; NanoPalm joint-venture; investment conference; DTC eligibility

As Drug Resistance Rises, GramEye and GSK Advance New AI-Led Infectious Disease Research

2 months ago talkbio0Tagged AI-driven, Antibiotics, Antimicrobial Resistance, Clinical Trials, Communicable Diseases, Drug Discovery, Gram-negative bacteria, GramEye, Mycoses, research, SmithKline Beecham, Staphylococcus aureus, superbugs

antimicrobial resistance (AMR); GramEye; GSK; AI-driven drug discovery; Gram-negative bacteria; Staphylococcus aureus; fungal infections; novel antibiotics; superbugs; infectious disease research; clinical trials

FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

2 months ago talkbio0Tagged Center for Drug Evaluation, Center for Drug Evaluation and Research, Drug Approval, George Tidmarsh, leadership instability, OCE, Oncology Center of Excellence, Project, regulatory reform, research, review delays, Richard Pazdur, United States Food and Drug Administration

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

Nkarta Reports Third Quarter 2025 Financial Results and Corporate Highlights

2 months ago talkbio0Tagged Capitalization, clinical-stage biopharma, development aspects, exophthalmos producing substance, financial results, Impaired, Market, net loss, Nkarta, Operating expenses, Q3, research

Nkarta; Q3 2025 financial results; net loss; operating expenses; EPS; research and development; impairment; market capitalization; clinical-stage biopharma; corporate highlights

Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

2 months ago talkbio0Tagged BEACON-IPF, cash reserves, Clinical Trials, development expenses, financial results, net loss, oncology program, Oxford Finance, Pliant Therapeutics, PLN-101095, Q3, research

Pliant Therapeutics; Q3 2025 financial results; PLN-101095; oncology program; BEACON-IPF trial; net loss; research and development expenses; cash reserves; Oxford Finance loan repayment

Roche Pays $55M Upfront to Manifold Bio in $2B+ Deal for AI-Guided Next-Gen Brain Shuttles

2 months ago talkbio0Tagged AI drug discovery, BBB, Blood - brain barrier anatomy, Manifold Bio, milestones, Neurological diseases, research, Roche (company), shuttles, therapeutic payloads, upfront payment

Roche; Manifold Bio; blood-brain barrier; BBB shuttles; neurological diseases; AI drug discovery; research deal; upfront payment; milestones; therapeutic payloads