Approved – Page 4

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

3 months ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

3 months ago talkbio0Tagged Approved, Bio, IBTROZI, Malignant neoplasm of lung, Nuvation, Oral treatment, Protein-tyrosine kinase inhibitor, ROS1-positive NSCLC, taletrectinib, United States Food and Drug Administration

Nuvation Bio; FDA approval; Ibtrozi; taletrectinib; lung cancer; ROS1-positive NSCLC; oral treatment; tyrosine kinase inhibitor

Merck Wins FDA Approval for RSV Antibody Drug, Intensifying Market Competition

3 months ago talkbio0Tagged Approved, AstraZeneca, competition, Enflonsia, Infant, Market, Merck, Monoclonal Antibodies, Respiratory syncytial virus, sanofi, United States Food and Drug Administration

Merck; FDA approval; RSV; monoclonal antibody; infants; Enflonsia; competitive market; Sanofi; AstraZeneca

Merck’s Enflonsia FDA Approval Spurs Sanofi to Accelerate Beyfortus Supply Ahead of 2025-26 RSV Season

3 months ago talkbio0Tagged Approved, AstraZeneca, Beyfortus, Enflonsia, Health care facility, Immunization, Infant, Merck, Respiratory syncytial virus, sanofi, supply chain, United States Food and Drug Administration

RSV; Infant immunization; Merck; Sanofi; Beyfortus; Enflonsia; FDA approval; supply chain; healthcare; AstraZeneca

AstraZeneca’s Calquence Combo Approved for First-Line CLL in EU

3 months ago talkbio0Tagged Amplify trial, Approved, AstraZeneca, BTK inhibitor, Calquence, Chronic Lymphocytic Leukemia, EU, First line treatment, obinutuzumab, venetoclax

AstraZeneca; Calquence; EU approval; chronic lymphocytic leukaemia; first-line treatment; venetoclax; obinutuzumab; BTK inhibitor; Amplify trial

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

3 months 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

3 months 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

3 months 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

3 months 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

3 months 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