|Articles|February 1, 2006

February 2006 FDA Pipeline

New molecular entities

New molecular entities

Nexavar
Sorafenib tablets
Bayer/OnyxORAL THERAPY APPROVED FOR THE TREATMENT OF ADVANCED RENAL CELL CARCINOMA

New indications

Avelox
Moxifloxacin
Bayer/Schering-PloughFLUOROQUINOLONE ANTIBIOTIC APPROVED FOR CIAI

Dosing. The recommended dose of moxifloxacin is 400 mg (orally or as an IV infusion) once every 24 hours. For cIAIs, therapy should usually be initiated with the IV formulation, and the duration of therapy should last from 5 to 14 days.

Newsletter

Get the latest industry news, event updates and more from Managed Healthcare Executive.

Subscribe

Latest CME

Audio

Show Me Your Care Plan!™ Insights for Oncology Nurses on Comprehensive SCLC Treatment and Care Strategies

Fred Hirsch, MD, PhD, FASCO; Andy Guinigundo, MSN, RN, CNP, ANP-BC, FAPO

Virtual Event

Optimizing NSCLC Readiness in the Era of TROP2-Targeted ADCs: Frontline Combinations, CNS Disease, and Toxicity Differentiation

June 22, 2026

Video

Tumor Board: Evolving Immunotherapy Strategies for Stage I-III NSCLC

Tina Cascone, MD, PhD; Puneeth Iyengar, MD, PhD; Paula A. Ugalde Figueroa, MD

Video

ADCs and Bispecific Antibodies Across Solid Tumors: Integrating New Targets, New Data, and New Decisions

William J. Gradishar, MD, FASCO, FACP; Rebecca Arend, MD, MSPH; Aaron Lisberg, MD; Ulka Vaishampayan, MD, FASCO

Video

Medical Crossfire®: Precision Oncology in NSCLC – Translating HER2 and TROP2 Innovation into Practice-Changing Care

Benjamin P. Levy, MD; Sarah Goldberg, MD, MPH; Jacob Sands, MD; Helena Yu, MD

Video

Tumor Board: Optimizing NSCLC Care—Leveraging the Latest Evidence on Targeted Therapy and Immuno-Oncology

Enriqueta Felip, MD, PhD; Justin Gainor, MD; Julia Rotow, MD; Urs Weber, MD

Video

(CME Credit) Advancing Outcomes in Limited-Stage Small Cell Lung Cancer: From Evidence to Practice

Lauren Averett Byers, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS

Video

Medical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 Dysregulation

Rebecca Heist, MD, MPH; Alex A. Adjei, MD, PhD, FACP; Sandip Patel, MD, FASCO; Jeremy Segal, MD, PhD

Video

Tumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLC

Balazs Halmos, MD, MS; Enriqueta Felip, MD, PhD; Julia Rotow, MD

Video

Medical Crossfire®: The Precision Path for HER2 and TROP2-Targeted Treatments in Non–Small Cell Lung Cancer

Benjamin P. Levy, MD; Ticiana Leal, MD; Aaron Lisberg, MD; Christine M. Lovly, MD, PhD, FASCO

Video

Medical Crossfire®: DLL3-Driven Innovations in Small Cell Lung Cancer – How Do Experts Apply Pivotal Advances to Practice?

Jacob Sands, MD; Jennifer Carlisle, MD; Hossein Borghaei, DO, MS

Video

PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies

Jonathan W. Goldman, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhD

In-Person Event

27th Annual International Lung Cancer Congress®

July 24-25, 2026

Register now!

Video

PER Global Perspectives: The TROP2-Targeted ADC Landscape in NSCLC and How to Interpret the Evidence

Solange Peters, MD, PhD; Benjamin P. Levy, MD; Tony S.K. Mok, MD, BMSc, FRCP(C), FRCP(Edin), FHKCP, FHKAM(Medicine), FASCO; Maurice Pérol, MD

Audio

Breaking Down the Latest Clinical Data for First-line Maintenance and R/R SCLC

Rahul Gosain, MD, MBA; Rohit Gosain, MD; Hossein Borghaei, DO, MS

Audio

Practical Considerations and Future Directions for New Treatment Strategies in SCLC

Rahul Gosain, MD, MBA; Rohit Gosain, MD; Misty D. Shields, MD, PhD

Audio

Navigating Treatment Gaps in SCLC: Relapse, Resistance, and Need for New Options

Rahul Gosain, MD, MBA; Rohit Gosain, MD; Giannis Mountzios ΜD, PhD

Multimedia

Community Practice Connections™: Distinguishing Precision Pathways for c-Met and MET Alterations in NSCLC

Jonathan Goldman, MD; Erminia Massarelli, MD, PhD, MS; Jorge J. Nieva, MD; Ignacio I. Wistuba, MD

Video

Advances in Managing EGFR-Mutant NSCLC: Applying Evidence Across the Disease Continuum

Tina Cascone, MD, PhD; Christina Baik, MD, MPH; David Planchard, MD, PhD

Video

A New Era of Targeted Therapy for Advanced NSCLC: Exploring Future Directions for Bispecific Antibodies and ADCs

Sandip Patel, MD, FASCO; Myung-Ju Ahn, MD; Giannis Mountzios, MD, MSc, PhD; Zofia Piotrowska, MD, MHS

Video

26th Annual International Lung Cancer Congress

Roy S. Herbst, MD, PhD; Sandip Patel, MD, FASCO; Heather A. Wakelee, MD, FASCO

Video

(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient Outcomes

Michelle L. Taylor, ANP-BC; Emely Alfaro, DNP, RN, CNS, OCN; Paige Griffith, CRNP; Beth Sandy, MSN, CRNP, FAPO

Multimedia

Personalized Approaches in NSCLC: Early Detection, Molecular Testing, and Targeted Therapies

Charu Aggarwal, MD, MPH, FASCO; Zofia Piotrowska, MD, MHS

Multimedia

Community Practice Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages

Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhD

Video

9th Annual School of Nursing Oncology™

Beth Faiman, PhD, MSN, APN-BC, BMTCN, AOCN, FAAN, FAPO; Beth Sandy, MSN, CRNP, FAPO; Lindsay Adkins, MSN, FNP-BC, BMTCN; Jeneth Aquino, DNP, FNP-BC; Casey Gormley, MSN, FNP-C, AOCNP; Heather J. Jackson, PhD, FNP-BC; Kelsey Martin, AG-ACNP-BC, AOCNP; Nerina T. McDonald, PA-C; Lauren Verity Moore, DNP, MSN, AGACNP-BC; Faith A. Mutale, DNP, CRNP; Tiffany Richards, PhD, ANP-BC, AOCNP; Emily Skotte, DNP, MSN, ACNP-BC; Leslie Smith, DNP, RN, APRN-CNS, AOCNS, BMTCN; Saneese Stephen, PA-C, MPAS; Sara M. Tinsley-Vance, PhD, APRN, AOCN

Multimedia

Community Practice Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer—From Innovation to Practice

Jacob Sands, MD; Anne Chiang, MD, PhD

Video

20th Annual New York Lung Cancers Symposium®

Balazs Halmos, MD, MS; Jamie Chaft, MD

February 2006 FDA Pipeline

Related Content

Adverse drug events after hospitalization: 'These are the sickest people that we have who are not in the hospital'

Putting pharmacists in charge of medication management as patients leave the hospital seems like a good idea. Does it work?

The Great Healthcare Plan, MFN drug prices and the political implications of the end of ACA enhanced subsidies: Here are 7 takeaways from the MHE-AJMC webinar

8 things you need to understand about tariffs on pharmaceuticals and other healthcare products after last week’s Supreme Court ruling

7 things you need to know about the PBM reforms signed into law this week

Latest CME

Show Me Your Care Plan!™ Insights for Oncology Nurses on Comprehensive SCLC Treatment and Care Strategies

Optimizing NSCLC Readiness in the Era of TROP2-Targeted ADCs: Frontline Combinations, CNS Disease, and Toxicity Differentiation

Tumor Board: Evolving Immunotherapy Strategies for Stage I-III NSCLC

ADCs and Bispecific Antibodies Across Solid Tumors: Integrating New Targets, New Data, and New Decisions

Medical Crossfire®: Precision Oncology in NSCLC – Translating HER2 and TROP2 Innovation into Practice-Changing Care

Tumor Board: Optimizing NSCLC Care—Leveraging the Latest Evidence on Targeted Therapy and Immuno-Oncology

(CME Credit) Advancing Outcomes in Limited-Stage Small Cell Lung Cancer: From Evidence to Practice

Medical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 Dysregulation

Tumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLC

Medical Crossfire®: The Precision Path for HER2 and TROP2-Targeted Treatments in Non–Small Cell Lung Cancer

Medical Crossfire®: DLL3-Driven Innovations in Small Cell Lung Cancer – How Do Experts Apply Pivotal Advances to Practice?

PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies

27th Annual International Lung Cancer Congress®

PER Global Perspectives: The TROP2-Targeted ADC Landscape in NSCLC and How to Interpret the Evidence

Breaking Down the Latest Clinical Data for First-line Maintenance and R/R SCLC

Practical Considerations and Future Directions for New Treatment Strategies in SCLC

Navigating Treatment Gaps in SCLC: Relapse, Resistance, and Need for New Options

Community Practice Connections™: Distinguishing Precision Pathways for c-Met and MET Alterations in NSCLC

Advances in Managing EGFR-Mutant NSCLC: Applying Evidence Across the Disease Continuum

A New Era of Targeted Therapy for Advanced NSCLC: Exploring Future Directions for Bispecific Antibodies and ADCs

26th Annual International Lung Cancer Congress

(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient Outcomes

Personalized Approaches in NSCLC: Early Detection, Molecular Testing, and Targeted Therapies

Community Practice Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages

9th Annual School of Nursing Oncology™

Community Practice Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer—From Innovation to Practice

20th Annual New York Lung Cancers Symposium®

Trending on Managed Healthcare Executive

CagriSema reduces HbA1c, weight across T2D spectrum in REIMAGINE trials | ADA 2026

Lee Kaplan, M.D., discusses the metabolic case for survodutide | ADA 2026

Nearly half of older adults with metastatic lung cancer never receive systemic therapy, study finds

Machine learning model predicts T2D risk up to 10 years before onset

Circulating tumor DNA shows prognostic power in early breast cancer, but clinical utility remains unproven