COVID19 (disease) – Talk Bio

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Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

2 weeks ago talkbio0Tagged Approved, concerns, COVID19 (disease), delays, Intact, Interferes with, Novavax, political, Regulation of biological process, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference

Invivyd Highlights Follow-Up to Pemgarda mAb Could Rival COVID Vaccines

2 weeks ago talkbio0Tagged Clinical Data, COVID19 (disease), immune compromise, Invivyd, long-acting protection, Monoclonal Antibodies, Pemgarda, vaccine alternatives

Invivyd; Pemgarda; VYD2311; monoclonal antibody; COVID-19; vaccine alternatives; immune compromise; long-acting protection; phase 1/2 clinical data

BioNTech Acquires CureVac to Advance mRNA Cancer Therapies and End Patent Disputes

3 weeks ago talkbio0Tagged Acquisition, BioNTech, biotech merger, COVID19 (disease), CureVac, Immunotherapy for cancer, Legal patent, Merger, RNA, Messenger, Vaccines

BioNTech; CureVac; mRNA; acquisition; COVID-19 vaccine; cancer immunotherapy; merger; patent dispute; biotech merger

FDA Approves Moderna’s Next-Generation Covid Vaccine With Limited Use for Most Healthy People

1 month ago talkbio0Tagged Approved, COVID19 (disease), Elderly (population group), high-risk, Moderna, next-generation Covid vaccine, Omicron, Omicron JN.1, restrictions, Spikevax, United States Food and Drug Administration, Vaccines, Variant

Moderna; FDA approval; mNexspike; next-generation Covid vaccine; vaccine restrictions; Covid-19; Spikevax; elderly; high-risk medical conditions; Omicron JN.1 variant

Moderna’s Next-Generation COVID Shot Gets FDA Backing With Usage Limitations

1 month ago talkbio0Tagged age restriction, Approved, conditions, COVID19 (disease), Effectiveness, mNEXSPIKE, Moderna, mRNA-1283, next-generation vaccine, respiratory virus season, United States Food and Drug Administration, Vaccines

Moderna; COVID-19 vaccine; FDA approval; mNEXSPIKE; mRNA-1283; next-generation vaccine; respiratory virus season; age restriction; underlying conditions; vaccine efficacy

Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

1 month ago talkbio0Tagged COVID19 (disease), flu/COVID-19, Moderna, Policy, Recommendation, Regulatory Setback, United States Food and Drug Administration, vaccine access, Vaccines

Moderna; COVID-19 vaccine; FDA policy; combination flu/COVID-19 shot; vaccine access; mRNA-1083; vaccine recommendations; regulatory setback

RFK Jr. Ends CDC Covid Vaccine Recommendations for Healthy Children and Pregnant Women

1 month ago talkbio0Tagged Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Child, COVID19 (disease), Pregnant Women, public health policy, Recommendation, RFK Jr., Secretary, Vaccines

RFK Jr.; COVID-19 vaccine; recommendations; children; pregnant women; CDC; HHS Secretary; public health policy

InflaRx Halts Rare Skin Disease Study for Vilobelimab After Futility Signal

1 month ago talkbio0Tagged Clinical Trials, COVID19 (disease), Drug Development, Futility, INF904, InflaRx, Pyoderma Gangrenosum, vilobelimab

InflaRx; vilobelimab; pyoderma gangrenosum; futility; clinical trial; COVID-19; drug development; INF904

FDA Expects ‘Timely Availability’ of Covid Shots as Advisors Update Formula Recommendation

2 months ago talkbio0Tagged Advisory Committees, Availability of, COVID19 (disease), formula update, JN.1-lineage, KP.2 strain, United States Food and Drug Administration, Vaccines

FDA; Covid-19; vaccine; formula update; timely availability; advisory committee; JN.1-lineage; KP.2 strain; 2025-2026

Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application

2 months ago talkbio0Tagged Biologics License Application, Clinical Trials, COVID19 (disease), Effectiveness, Influenza, Moderna, mRNA-1083, Prices, United States Food and Drug Administration, Vaccines, Vaccines, Combined

Moderna; mRNA-1083; combination vaccine; flu; COVID-19; FDA; Biologics License Application; vaccine efficacy; clinical trial; share price