News|Articles|May 1, 2008

FDA Pipeline preview, May 2008

Recent FDA action (through May 2008) related to ceftobiprole, sugammadex, romiplostim, Gardasil, and amrubicin.

Approvable designation

Recommended for approval

Priority review

Orphan drug designation

Newsletter

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

Subscribe Now!

Related Content

Latest CME

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Louisiana
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Louisiana

Jacob Sands, MD; Uday Dandamudi, MD

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Montana and Wyoming
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Montana and Wyoming

Jacob Sands, MD; Brian Vicuna, MD

View more
From Clue to Care: Rapid Recognition and Coordinated Management of Paraneoplastic LEMS in SCLC
In-Person + Virtual Event

From Clue to Care: Rapid Recognition and Coordinated Management of Paraneoplastic LEMS in SCLC

December 5, 2025

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | New Mexico
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | New Mexico

Jacob Sands, MD; Gemlyn George, MD, MS

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Wisconsin
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Wisconsin

Anne Chiang, MD, PhD; Faysal Haroun, MD

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Missouri
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Missouri

Jacob Sands, MD; Andrew Kovoor, MD

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Kentucky
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Kentucky

Anne Chiang, MD, PhD; Baidehi Maiti, MD, PhD, FACP

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Indiana
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | Indiana

Anne Chiang, MD, PhD; Xuan Huang, MD, PhD

View more
Burst CME™: Addressing Diagnostic Challenges and Identifying Targets for Treatment in LCNEC-L
Multimedia

Burst CME™: Addressing Diagnostic Challenges and Identifying Targets for Treatment in LCNEC-L

Jacob Sands, MD; Martin Wermke, MD

View more
Burst CME™: Advanced Diagnostic and Testing Approaches for Mutation-Targetable Management of NSCLC
Multimedia

Burst CME™: Advanced Diagnostic and Testing Approaches for Mutation-Targetable Management of NSCLC

Jacob Sands, MD; Julia Rotow, MD

View more
Burst CME™: Exploring Diagnosis and Testing Innovations for Targetable Mutations in SCLC
Multimedia

Burst CME™: Exploring Diagnosis and Testing Innovations for Targetable Mutations in SCLC

Jacob Sands, MD; Carl M. Gay, MD, PhD

View more
Community Oncology Connections ™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | Missouri
Video

Community Oncology Connections ™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | Missouri

Erminia Massarelli, MD, PhD, MS; Rashad Khan, MD

View more
Community Oncology Connections ™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | New Mexico
Video

Community Oncology Connections ™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | New Mexico

Erminia Massarelli, MD, PhD, MS; Sandhya Sharma, MD

View more
Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | North Carolina
Video

Community Oncology Connections™: DLL3-Targeting Bispecific Antibodies for Small Cell Lung Cancer – From Innovation to Practice | North Carolina

Jacob Sands, MD; Venu Madhav Konala, MD, FACP

View more
Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | West Virginia
Video

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | West Virginia

Zofia Piotrowska, MD, MHS; Alejandro R. Calvo, MD, FACP

View more
From Suspicion to Stabilization: Early Recognition and Treatment of Paraneoplastic LEMS
Video

From Suspicion to Stabilization: Early Recognition and Treatment of Paraneoplastic LEMS

Charu Aggarwal, MD, MPH, FASCO; Erminia Massarelli, MD, PhD, MS; Ruham Nasany, MD

View more
Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Tennessee
Video

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Tennessee

Zofia Piotrowska, MD, MHS; Swati Vishwanathan, MD

View more
Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Washington
Video

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Washington

Zofia Piotrowska, MD, MHS; Robert Hsu, MD

View more
Community Oncology Connections ™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | Texas
Video

Community Oncology Connections ™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | Texas

Millie Das, MD; Rebecca Yarborough, MD

View more
Inaugural Brain & Spine Metastases Conference: Evolving Practice and Emerging Therapies
In-Person Event

Inaugural Brain & Spine Metastases Conference: Evolving Practice and Emerging Therapies

January 22, 2026

Register now!
2nd Annual Hawaii Cancer Conference
In-Person Event

2nd Annual Hawaii Cancer Conference

January 24-25, 2026

Register now!
23rd Annual Winter Lung Cancer Conference®
In-Person Event

23rd Annual Winter Lung Cancer Conference®

January 23-25, 2026

Register now!
Future Directions in Treating SCLC and LCNEC-L: The Impact of DLL3
Multimedia

Future Directions in Treating SCLC and LCNEC-L: The Impact of DLL3

Jacob Sands, MD; Carl M. Gay, MD, PhD

View more
Burst CME™: The Role of HER2 in NSCLC and Implications for Emerging Treatment Strategies
Multimedia

Burst CME™: The Role of HER2 in NSCLC and Implications for Emerging Treatment Strategies

Jacob Sands, MD; Julia Rotow, MD

View more
Community Practice Connections™: 19th Annual New York Lung Cancers Symposium®
Multimedia

Community Practice Connections™: 19th Annual New York Lung Cancers Symposium®

Balazs Halmos, MD, MS; Mark G. Kris, MD; Jamie E. Chaft, MD; Zofia Piotrowska, MD, MHS

View more
42nd Annual CFS: Chemotherapy Foundation Symposium®: Innovative Cancer Therapy for Tomorrow
Multimedia

42nd Annual CFS: Chemotherapy Foundation Symposium®: Innovative Cancer Therapy for Tomorrow

Benjamin P. Levy, MD; John O. Mascarenhas, MD; Tiffany A. Traina, MD, FASCO; Cathy Eng, MD, FACP, FASCO; John P. Leonard, MD

View more
A Breath of Strength: Managing Cancer Associated LEMS and Lung Cancer as One
Video

A Breath of Strength: Managing Cancer Associated LEMS and Lung Cancer as One

Estelamari Rodriguez, MD, MPH; Millie Das, MD; Ruham Nasany, MD

View more
Striking the Right Nerve: Managing Cancer Associated LEMS in Lung Cancer Patients
Video

Striking the Right Nerve: Managing Cancer Associated LEMS in Lung Cancer Patients

Anne Chiang, MD, PhD; J. Douglas Miles, MD, PhD, FAAN; Suma Satti, MD

View more
3rd Annual Hawaii Lung: A Multidisciplinary Case-Based Conference
Video

3rd Annual Hawaii Lung: A Multidisciplinary Case-Based Conference

David R. Gandara, MD; Roy S. Herbst, MD, PhD; Heather A. Wakelee, MD, FASCO

View more
Community Practice Connections™: Incorporating Recent Updates in the Treatment of Metastatic ALK-Positive NSCLC
Multimedia

Community Practice Connections™: Incorporating Recent Updates in the Treatment of Metastatic ALK-Positive NSCLC

Zofia Piotrowska, MD, MHS; Bruna Pellini, MD; Alice Shaw, MD, PhD

View more
Virtual Testing Board: Digging Deeper on Your Testing Reports to Elevate Patient Outcomes in Advanced Non–Small Cell Lung Cancer
Video

Virtual Testing Board: Digging Deeper on Your Testing Reports to Elevate Patient Outcomes in Advanced Non–Small Cell Lung Cancer

Stephen V. Liu, MD; Michelle Afkhami, MD; Ignacio I. Wistuba, MD; Helena Yu, MD

View more
Mastering Advances in Managing Unresectable and Metastatic NSCLC—Immunotherapy, Targeted Therapies, and Emerging Strategies
Video

Mastering Advances in Managing Unresectable and Metastatic NSCLC—Immunotherapy, Targeted Therapies, and Emerging Strategies

Marina Chiara Garassino, MD; Sarah Goldberg, MD, MPH; Biagio Ricciuti, MD, PhD

View more
Cases & Conversations™: Expert Perspectives on Leveraging Recent Advances to Transform SCLC Treatment
Video

Cases & Conversations™: Expert Perspectives on Leveraging Recent Advances to Transform SCLC Treatment

Jacob Sands, MD; Anne Chiang, MD, PhD; Alissa J. Cooper, MD

View more
22nd Annual Winter Lung Cancer Conference®
Video

22nd Annual Winter Lung Cancer Conference®

Julie Brahmer, MD; Rogerio C. Lilenbaum, MD, FACP, FASCO; Mark A. Socinski, MD

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

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

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

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

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

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

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

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

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

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

View more
Practical Considerations and Future Directions for New Treatment Strategies in SCLC
Audio

Practical Considerations and Future Directions for New Treatment Strategies in SCLC

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

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

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

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

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

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

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

View more
26th Annual International Lung Cancer Congress
Video

26th Annual International Lung Cancer Congress

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

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

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

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

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

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

View more
9th Annual School of Nursing Oncology™
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

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

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

Jacob Sands, MD; Anne Chiang, MD, PhD

View more
(Pharmacist Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient Outcomes
Video

(Pharmacist 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

View more
27th Annual International Lung Cancer Congress®
In-Person Event

27th Annual International Lung Cancer Congress®

July 24-25, 2026

Register now!
21st Annual New York Lung Cancers Symposium®
In-Person Event

21st Annual New York Lung Cancers Symposium®

November 14, 2026

Register now!
Contact Info

259 Prospect Plains Rd, Bldg H
Cranbury, NJ 08512

609-716-7777

Managed Healthcare Executive
Brand Logo

© 2025 MJH Life Sciences®

All rights reserved.

Home
About Us
News
Contact Us