News|Articles|August 1, 2008

FDA Pipeline preview, August 2008

Recent FDA action (through August 2008) related to long-acting depot preparation of testosterone, pancrealipase capsules, human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant, tolvaptan, etanercept, ustekinumab, and cysteamine hydrocortisone dual-release table.

Approvable designations

Complete response

Recommended for approval

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 | 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
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
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®: 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