New Drugs and Expanded Indications

Below are postings for new drugs and indications from our corporate sponsors you should be aware of.  Please refer to the links below for announcements and details. To view a full list of approvals, please visit www.fda.gov.

To view current and resolved drug shortages and discontinuations reported to FDA click here. 

09/27/2023

FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions

08/16/2023

FDA Grants Accelerated Approval to Pfizer’s ELREXFIO for Relapsed or Refractory Multiple Myeloma

08/16/2023

FDA Approves Janssen's AKEEG (Niraparib and Abiraterone Acetate), the First-AndOnly Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

08/11/2023

FDA Approves Genentech's Gavreto (pralsetinib) for Adult Patients with Metastatic Rearranged During Transfection (RET) Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)

08/10/2023

FDA Approves Janssen's TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma

08/03/2023

FDA Approves Taiho Oncology's LONSURF® (trifluridine/tipiracil) in Combination with bevacizumab for the Treatment of Adult Patients with Metastatic Colorectal Cancer (mCRC)

08/01/2023

FDA Approves GSK's Jemperli (dostarlimab-gxly) plus chemotherapy as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

07/21/2023

FDA Approves Daiichi Sankyo's VANFLYTA® (quizartinib) With Standard Cytarabine and Anthracycline Induction and Cytarabine Consolidation, for the Treatment of Adult Patients with Acute Myeloid Leukemia

06/22/2023

FDA Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration Resistant Prostate Cancer (mCRPC)

06/19/2023

FDA Approves Genentech’s Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

06/01/2023

FDA Approves AstraZeneca's Lynparza Plus Abiraterone for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

05/19/2023

FDA Approves Genmab's and AbbVie's EPKINLY™ (epcoritamab-bysp) as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

04/24/2023

FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma

04/04/2023

FDA Grants Accelerated Approval for Astellas & SeaGen PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer

Therapies

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