Logo Image
News|Articles|March 1, 2012

FDA Pipeline Preview, March 2012 (ViroPharma, Novartis, Amgen, Del Mar Pharmaceuticals, CSL Behring, Genentech, Salix, Gilead, Pfizer, Repligen)

Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate

Complete response

Not recommended for approval

Orphan drug designations

Related Content

Latest CME

Optimizing NSCLC Readiness in the Era of TROP2-Targeted ADCs: Frontline Combinations, CNS Disease, and Toxicity Differentiation
Virtual Event

Optimizing NSCLC Readiness in the Era of TROP2-Targeted ADCs: Frontline Combinations, CNS Disease, and Toxicity Differentiation

2-Part Webinar Series

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

27th Annual International Lung Cancer Congress®

July 24-25, 2026

Register now!
PER Global Perspectives: The TROP2-Targeted ADC Landscape in NSCLC and How to Interpret the Evidence
Video

PER Global Perspectives: The TROP2-Targeted ADC Landscape in NSCLC and How to Interpret the Evidence

Solange Peters, MD, PhD; Benjamin P. Levy, MD; Tony S.K. Mok, MD, BMSc, FRCP(C), FRCP(Edin), FHKCP, FHKAM(Medicine), FASCO; Maurice Pérol, MD

View more
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
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
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
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
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
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
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