News|Articles|February 1, 2008

FDA Pipeline Preview, February 2008

FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120

Approvable designations

Complete response letter

Nonapprovable designations

Fast-track designations

Priority review

Orphan drug designations

Newsletter

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

Subscribe Now!

Related Content

Latest CME

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

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

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

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

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

Charu Aggarwal, MD, MPH, FASCO; Andy Jang, 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!
Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Nevada
Multimedia

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

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

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

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

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

View more
23rd Annual Winter Lung Cancer Conference®
In-Person Event

23rd Annual Winter Lung Cancer Conference®

January 23-25, 2026

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

2nd Annual Hawaii Cancer Conference

January 24-25, 2026

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

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

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

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

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

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

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

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

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

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

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

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

Zofia Piotrowska, MD, MHS; Shan Guo, MD

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

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
Huntington Beach Symposia
In-Person + Virtual Event

Huntington Beach Symposia

February 19-21, 2026

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

27th Annual International Lung Cancer Congress®

July 24-25, 2026

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

21st Annual New York Lung Cancers Symposium®

November 14, 2026

Register now!
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
20th Annual New York Lung Cancers Symposium®
Video

20th Annual New York Lung Cancers Symposium®

Balazs Halmos, MD, MS; Jamie Chaft, MD

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

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

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

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

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

View more