Medicines Press Releases

06.07.2018

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

06.04.2018

Two-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses with BAVENCIO® (avelumab)

06.01.2018

Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, TRAZIMERA™ (trastuzumab)

05.30.2018

Pfizer Announces U.S. FDA Approves XELJANZ® (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis

05.29.2018

Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications

05.17.2018

LYRICA® (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

05.15.2018

Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

04.23.2018

Pfizer Provides Update on Proposed Trastuzumab Biosimilar

04.23.2018

MYLOTARG™ Approved In The EU For The Treatment Of Previously Untreated, De Novo, CD33-positive Acute Myeloid Leukemia In Combination With Chemotherapy

04.04.2018

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations

03.19.2018

U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

03.08.2018

Pfizer Announces Favorable Outcome of FDA Advisory Committee Meeting on XELJANZ® (tofacitinib) for Moderately to Severely Active Ulcerative Colitis