News|Articles|September 1, 2009

FDA Pipeline preview, September 2009 (cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, beclomethasone 17,21-dipropionate)

Recent FDA action (through September 2009) related to cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, and beclomethasone 17,21-dipropionate

Complete response

Recommended for approval

Not recommended for approval

Orphan drug designation

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

Latest CME

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®: 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

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

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

Virtual Event

Oncology Town Hall: From Evidence to Action—Applying KRAS-Targeted Advances in Solid Tumors

July 14, 2026

In-Person Event

27th Annual International Lung Cancer Congress®

July 24-25, 2026

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

Video

PER Global Perspectives: Preparing for the Emergence of TROP2 ADCs With Immunotherapy in the Earlier Treatment Settings

Solange Peters, MD, PhD; Myung-Ju Ahn, MD, PhD; Luis Paz-Ares, MD, PhD; Jacob Sands, MD

Video

PER Global Perspectives: Differentiating and Managing Toxicities with TROP2-Targeted ADCs in NSCLC Through Multidisciplinary Pathways

Solange Peters, MD, PhD; Stephanie McDonald, FNP-BC, AOCNP; Antonio Passaro, MD, PhD; Jacob Sands, 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

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

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

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

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™: 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

FDA Pipeline preview, September 2009 (cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, beclomethasone 17,21-dipropionate)

Related Content

Vitiligo is associated with mental heath conditions, other autoimmune diseases

Centanafadine hits primary and key secondary endpoints in ADHD phase 3b trial

A conversation about vaccines and monoclonal antibodies with Marc Elia, Chairman of Invivyd’s Board of Directors

New study confirms benefits of GLP-1 drugs in patients with PAD

Neffy’s first year: $72.2m in sales, 10,000 schools and broadening payer access

Latest CME

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

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?

PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies

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

Oncology Town Hall: From Evidence to Action—Applying KRAS-Targeted Advances in Solid Tumors

27th Annual International Lung Cancer Congress®

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

PER Global Perspectives: Preparing for the Emergence of TROP2 ADCs With Immunotherapy in the Earlier Treatment Settings

PER Global Perspectives: Differentiating and Managing Toxicities with TROP2-Targeted ADCs in NSCLC Through Multidisciplinary Pathways

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

26th Annual International Lung Cancer Congress

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

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

9th Annual School of Nursing Oncology™

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

Trending on Managed Healthcare Executive

Neffy’s first year: $72.2m in sales, 10,000 schools and broadening payer access

Centanafadine hits primary and key secondary endpoints in ADHD phase 3b trial

New study confirms benefits of GLP-1 drugs in patients with PAD

A conversation about vaccines and monoclonal antibodies with Marc Elia, Chairman of Invivyd’s Board of Directors

Brukinsa/rituximab cuts progression risk 43% in mantle cell lymphoma