Manufactured Object

FDA Requests Flu Vaccine Label Updates for Febrile Seizure Risk in Young Children

2 weeks ago talkbio0Tagged Child, Febrile Convulsions, Influenza virus vaccine, Labels (device), United States Food and Drug Administration, update, Vaccines

FDA; flu vaccine; febrile seizures; label update; children; influenza vaccine

Novartis Announces Fourth US Radioligand Therapy Facility in Winter Park, Florida

2 weeks ago talkbio0Tagged Cancer Therapeutic Procedure, Florida, Manufacturing Facilities, Novartis, radioligand therapy, Winter Park

Novartis; radioligand therapy; Florida; Winter Park; manufacturing facility; cancer treatment

Aktis Oncology’s 25% IPO jump lifts optimism for a biotech IPO rebound in 2026

2 weeks ago talkbio0Tagged Aktis, AKTS, Biotech IPOs, bounce, Capital Markets, CD276 gene, Eli Lilly backing, IPO, NECTIN4 gene, Neoplasms, Radiopharmaceuticals, Window (physical object)

Aktis Oncology IPO; AKTS; 2026 biotech IPOs; IPO bounce; radiopharmaceuticals; Eli Lilly backing; biotech capital markets; Nectin-4; B7-H3; IPO window 2026

FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

2 weeks ago talkbio0Tagged Circadian Rhythms, Clinical Trial Design, collaborative framework agreement, decision letter, expansion, Hetlioz, jet lag disorder, Labels (device), NDA, phase advance protocol, Rejection, Sleep Disorders, Supplement, tasimelteon, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute

AstraZeneca appoints Rick R. Suarez to lead U.S. BioPharmaceuticals business and $50B investment drive

2 weeks ago talkbio0Tagged AstraZeneca, Biological Factors, Head of US, Investments, President brand of dental material, Rick R. Suarez, Surgical aspects, U.S., Virginia manufacturing facility, Wilmington Delaware

AstraZeneca; Rick R. Suarez; US President; Head of US BioPharmaceuticals Business Unit; $50 billion US investment; Virginia manufacturing facility; US operations; biopharmaceuticals; revenue goal 2030; Wilmington Delaware

Just – Evotec Biologics Receives Gates Foundation Grant for AI-Driven Optimization of Monoclonal Antibody Developability

2 weeks ago talkbio0Tagged AI-driven, biotherapeutics, Country, developability, Drug Kinetics, Evotec SE, Financial cost, funding grant, Gates Foundation * *, Global Health, HIV, Immunogenicity (package insert), J.MD, low, Malaria, manufacturability, Manufactured Supplies, middle-income, Monoclonal Antibodies, Optimization, Platform, Respiratory syncytial virus, Stable status, Titer

Evotec SE; Gates Foundation; grant; J.MD; J.DESIGN platform; AI-driven optimization; monoclonal antibodies; biotherapeutics; developability; manufacturability; stability; immunogenicity; pharmacokinetics; titer; cost of goods; global health; affordable access; low- and middle-income countries; RSV; malaria; HIV