News|Articles|February 1, 2010

FDA Pipeline preview, February 2010 (Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126)

Recent FDA action (through February 2010) related to Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126

Complete response

Recommended for approval

Not 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™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | Wisconsin

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

In-Person Event

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

January 22, 2026

Video

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

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

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

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

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

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

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

Video

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

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

Video

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

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

Video

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

Zofia Piotrowska, MD, MHS; Shan Guo, MD

Video

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

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

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

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

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

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

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

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

In-Person Event

21st Annual New York Lung Cancers Symposium®

November 14, 2026

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

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

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

FDA Pipeline preview, February 2010 (Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126)

Newsletter

Related Content

AHIP lays blame for rising healthcare costs on hospitals, private equity

Sleep deprivation impairs teamwork, productivity

New advisory firm assesses health vendors for fiduciary integrity

Patients often misunderstand common skin cancer terms, survey finds

FDA accepts NDA for gedatolisib, Celcuity’s investigational breast cancer treatment

Latest CME

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

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

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

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

2nd Annual Hawaii Cancer Conference

23rd Annual Winter Lung Cancer Conference®

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

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

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

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

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

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

Huntington Beach Symposia

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

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

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

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

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®

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

21st Annual New York Lung Cancers Symposium®

9th Annual School of Nursing Oncology™

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

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

Trending on Managed Healthcare Executive

Sanofi acquires Dynavax for $2.2 billion to bolster vaccine portfolio

Patients may not see savings from new Medicare drug programs

FDA accepts NDA for gedatolisib, Celcuity’s investigational breast cancer treatment

Why Timing, Access and Interpretation Matter in Oncology Biomarker Testing

New study examines safety and effectiveness of stereotactic radiotherapy in NSCLC with ILD