News|Articles|May 1, 2011

FDA Pipeline Preview, May 2011 (Eli Lilly, Vertex, Regeneron Pharmaceuticals, Nile Therapeutics, Provectus)

Recent FDA action (through April 2011) related to Liprotamase, Aricept Patch, Telaprevir, Restylane Injectable Gel, VEGF Trap-Eye, Cenderitide, PV-10, INNO-206

Complete response

Recommended for approval

Priority review

Orphan drug designation

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

Subscribe Now!

Latest CME

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

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

Video

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

Jacob Sands, MD; Andrew Kovoor, MD

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

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

Multimedia

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

Jacob Sands, MD; Martin Wermke, MD

Multimedia

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

Jacob Sands, MD; Julia Rotow, MD

Multimedia

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

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

Video

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

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

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

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

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

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

Video

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

Zofia Piotrowska, MD, MHS; Swati Vishwanathan, MD

Video

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

Zofia Piotrowska, MD, MHS; Robert Hsu, MD

Video

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

Millie Das, MD; Rebecca Yarborough, MD

Video

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

Charu Aggarwal, MD, MPH, FASCO; Philip A. Haddad, MD, MPH, MHA, MS(HCI)

Video

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

Charu Aggarwal, MD, MPH, FASCO; Jack W. Erter III, MD, MMHC

In-Person Event

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

January 22, 2026

In-Person Event

2nd Annual Hawaii Cancer Conference

January 24-25, 2026

In-Person Event

23rd Annual Winter Lung Cancer Conference®

January 23-25, 2026

Multimedia

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

Jacob Sands, MD; Julia Rotow, MD

Multimedia

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

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

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

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

Video

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

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

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

Video

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

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

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

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

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

Video

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

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

Video

22nd Annual Winter Lung Cancer Conference®

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

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

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

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

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®: 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

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

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

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

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

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

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

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

(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

In-Person Event

27th Annual International Lung Cancer Congress®

July 24-25, 2026

In-Person Event

21st Annual New York Lung Cancers Symposium®

November 14, 2026

FDA Pipeline Preview, May 2011 (Eli Lilly, Vertex, Regeneron Pharmaceuticals, Nile Therapeutics, Provectus)

Newsletter

Related Content

AstraZeneca’s Imfinzi gains landmark FDA approval for early gastric and gastroesophageal cancers

Quadruplet treatments for multiple myeloma are rising but access varies | ASH 2025

Brainomix 360 e-Lung Technology speeds up PPF detection

Hydrotherapy more beneficial for MS patients than conventional physiotherapy

Blocking microRNA may slow bladder cancer growth

Latest CME

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

2nd Annual Hawaii Cancer Conference

23rd Annual Winter Lung Cancer Conference®

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

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

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

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

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

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

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

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

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

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

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

22nd Annual Winter Lung Cancer Conference®

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

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

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

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

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

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

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

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

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

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

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

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

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

27th Annual International Lung Cancer Congress®

21st Annual New York Lung Cancers Symposium®

Trending on Managed Healthcare Executive

ACIP to vote on major hepatitis B vaccine update that could reshape the childhood vaccine schedule

Transplant-fueled hybrid immune systems may help reverse Type 1 diabetes

ACIP votes to end universal birth-dose for hepatitis B vaccine with updated guidance for parents and doctors

New test may solve the specificity and false-positive problems of the PSA test for prostate cancer

Quadruplet treatments for multiple myeloma are rising but access varies | ASH 2025