Approved – Talk Bio

RadNet Acquires See-Mode to Expand AI Ultrasound for Breast and Thyroid Cancer Diagnostics

2 days ago talkbio0Tagged Acquisition, AI ultrasound, Approved, DeepHealth, Diagnostic Imaging, Malignant neoplasm of breast, Malignant neoplasm of thyroid, RadNet, See-Mode, Technology, United States Food and Drug Administration, workflow efficiency

RadNet; See-Mode Technologies; AI ultrasound; breast cancer; thyroid cancer; DeepHealth; diagnostic imaging; FDA approval; workflow efficiency; acquisition

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

4 days 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

J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

4 days ago talkbio0Tagged Akeega, Amplitude, Approved, BRCA, HRR gene, Inhibitor, J&J, Malignant neoplasm of prostate, mCSPC, Metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, Mutation, PARP1 gene, United States Food and Drug Administration

Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)

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

6 days 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

Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline

1 week ago talkbio0Tagged AERIFY-1, AERIFY-2, Approved, Clinical Trials, COPD, IL33 protein, human, itepekimab, Regeneron, sanofi, United States Food and Drug Administration

Sanofi; Regeneron; COPD; itepekimab; IL-33; Phase 3 trials; AERIFY-1; AERIFY-2; FDA approval; clinical trial results

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

1 week ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

FDA Approves Novavax COVID Vaccine After Delay, Limits Use to Smaller High-Risk Population

3 weeks ago talkbio0Tagged Approved, COVID19 (disease), Elderly (population group), Health conditions:-:Point in time:^Patient:-, Novavax, Nuvaxovid, protein-based vaccine, restricted population, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; Nuvaxovid; restricted population; protein-based vaccine; older adults; underlying health conditions

Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost

3 weeks ago talkbio0Tagged Adoption, Alzheimer 's disease, Approved, AutoInjector, Biogen, dosing, Eisai, Hematologic Tests, launch, Leqembi, Maintenance, Market, subcutaneous, United States Food and Drug Administration

Leqembi; Eisai; Biogen; Alzheimer’s disease; FDA approval; blood test; launch; maintenance dosing; autoinjector; subcutaneous; market adoption

Pfizer-backed CellCentric Secures $120M for Myeloma Drug Trials

3 weeks ago talkbio0Tagged Accelerated, Approved, CellCentric, Clinical Trials, Inobrodib, Multiple Myeloma, oral drug, p300/CBP inhibitor, Pfizer, Series C

CellCentric; Pfizer; multiple myeloma; Series C funding; inobrodib; p300/CBP inhibitor; oral drug; clinical trials; phase 2/3; accelerated approval

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

3 weeks ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy