News|Articles|April 1, 2009

FDA Pipeline preview, April 2009 (alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, EUR-1073)

Recent FDA action (through April 2009) related to alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, and EUR-1073

Complete response

Priority review

Orphan drug designations

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Latest CME

Video

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

Anne Chiang, MD, PhD; Benjamin Scheier, MD

Video

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

Anne Chiang, MD, PhD; Adriana L. Alvarez, MD

Video

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

Misty D. Shields, MD, PhD; Ananth Arjunan, MD

Multimedia

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

Zofia Piotrowska, MD, MHS; Helen H. Moon, MD

Video

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

Misty D. Shields, MD, PhD; Horace Tang, MD

Video

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

Erminia Massarelli, MD, PhD, MS; Parth Khade, MD

Video

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

Misty D. Shields, MD, PhD; Chandler Park, MD, MSc, FACP

Video

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

Misty D. Shields, MD, PhD; Rujul Parikh, MD

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

Charu Aggarwal, MD, MPH, FASCO; Yifan Tu, MD, PhD

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

Charu Aggarwal, MD, MPH, FASCO; Mo Ziari, MD

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

Zofia Piotrowska, MD, MHS; Shan Guo, MD

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

Misty D. Shields, MD, PhD; Michelle Ojemuyiwa, 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

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

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

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

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

(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

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

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

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

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

Video

Cases and Conversations™: Transforming Small Cell Lung Cancer Treatment Through Emerging Evidence and Expert Insights

Charles M. Rudin, MD, PhD; Anne Chiang, MD, PhD, FASCO; Jacob M. Sands, MD

Video

Hot Seat: Converging Lines in the Management of RAS-Altered Cancers

Shubham Pant, MD, MBBS; Alison Schram, MD; Helena Yu, MD

Video

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

Millie Das, MD; Wade Iams, MD, MSCI; Ruham Nasany, MD

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

(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

Video

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

Erminia Massarelli, MD, PhD, MS; Frantz Francisque, MD

Video

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

Charu Aggarwal, MD, MPH, FASCO; Andy Jang, MD

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

In-Person + Virtual Event

Show Me the Data™: Incorporating the Latest Advances in Immunotherapy and EGFR-Targeted Treatments for Resectable Early-Stage NSCLC

January 29, 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

In-Person + Virtual Event

Huntington Beach Symposia

February 19-21, 2026

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

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

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

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

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

26th Annual International Lung Cancer Congress

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

In-Person Event

21st Annual New York Lung Cancers Symposium®

November 14, 2026

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

FDA Pipeline preview, April 2009 (alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, EUR-1073)

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

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

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

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

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

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

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

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

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

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

22nd Annual Winter Lung Cancer Conference®

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

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

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

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

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

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

9th Annual School of Nursing Oncology™

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

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

20th Annual New York Lung Cancers Symposium®

Cases and Conversations™: Transforming Small Cell Lung Cancer Treatment Through Emerging Evidence and Expert Insights

Hot Seat: Converging Lines in the Management of RAS-Altered Cancers

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

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

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

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

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

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

2nd Annual Hawaii Cancer Conference

23rd Annual Winter Lung Cancer Conference®

Show Me the Data™: Incorporating the Latest Advances in Immunotherapy and EGFR-Targeted Treatments for Resectable Early-Stage NSCLC

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

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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

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

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