Talk Bio – Page 20 – Actionable Insights Powered by AI

Geron Corporation Announces Executive Leadership Transitions and Appointments

3 weeks ago talkbio0Tagged Ahmed ElNawawi, Andrew Grethlein, Appointments, commercial strategy, departures, executive leadership, Geron Corporation, Harout, Rytelo, Semerjian

Geron Corporation; executive leadership; appointments; departures; commercial strategy; RYTELO; Harout Semerjian; Ahmed ElNawawi; Andrew Grethlein; Jim Ziegler

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

3 weeks ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

REACtiVe-2 Phase 1 Data Show Immune Activation in Pancreatic Cancer Treatment with Mitazalimab

4 weeks ago talkbio0Tagged Immune Activation, mitazalimab, REACtiVe-2, Secondary malignant neoplasm of pancreas

Mitazalimab; REACtiVe-2; Metastatic Pancreatic Cancer; Immune Activation

Novo Nordisk Ends Cell Therapy Research Amid Major Restructuring

4 weeks ago talkbio0Tagged cancellations, Cell Therapy, cost-cutting, Diabetes, Novo Nordisk, Obesity, Partnership, R&D strategy, restructuring

Novo Nordisk; cell therapy; restructuring; job cuts; diabetes; cost-cutting; R&D strategy; biotech; obesity; partnership cancellations

FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval

4 weeks ago talkbio0Tagged 2025, CBER, CDER, Drug Approval, molecular entities, trends qualifier, United States Food and Drug Administration

FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs

No Recent News Specifically About ‘Click here to continue reading’

4 weeks ago talkbio0Tagged internet phrase, News [Publication Type], Reading (activity), web navigation

click here to continue reading; news; recent news; web navigation; internet phrase

AstraZeneca Reaches Drug Pricing Deal with White House, Becomes Second Pharma to Do So

4 weeks ago talkbio0Tagged AstraZeneca, drug discounts, drug price, Medicaid, most-favored-nation pricing, Pfizer, tariffs, TrumpRx, White House

AstraZeneca; White House; drug pricing; Medicaid; TrumpRx; most-favored-nation pricing; tariffs; Pfizer; drug discounts

Regeneron Heads to FDA Seeking Approval for Game-Changing Hearing Loss Gene Therapy

4 weeks ago talkbio0Tagged Approved, CHORD trial, DB-OTO, Deafness, gene therapy, OTOF gene, Regeneron, United States Food and Drug Administration

Regeneron; hearing loss; gene therapy; DB-OTO; FDA approval; OTOF gene; CHORD trial

Ypsomed Invests $248 Million to Establish First U.S. Manufacturing Site in North Carolina

4 weeks ago talkbio0Tagged CHF, expansion, Facility (object), global growth strategy, Holly Springs, Manufacturing, medical technology, North Carolina, self-injection systems, Surgical construction, United States, Ypsomed

Ypsomed; manufacturing expansion; U.S. facility; Holly Springs; North Carolina; CHF 200 million; self-injection systems; job creation; global growth strategy; medical technology

Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million

4 weeks ago talkbio0Tagged Child, Fund Raising, Idorsia, Indonesian language, Muscular Dystrophy, Duchenne, oral small-molecule therapy, Phase 2 clinical trial, SAT-3247, Satellos, Submission, United States Food and Drug Administration

Satellos; Duchenne muscular dystrophy; SAT-3247; Phase 2 clinical trial; children; FDA IND submission; oral small-molecule therapy; Idorsia; fundraising; biotech