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Press Release Archive

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

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration...

 
- Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) will present findings today from a real-world data (RWD) analysis titled, Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients Treated in US Clinical Practice.

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

NEW YORK, N.Y., March 8, 2018 – Pfizer Inc. announced a positive outcome from today’s U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting. The GIDAC met to discuss Pfizer’s supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

 
- Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference

Pfizer invites investors and the general public to view and listen to a webcast of a presentation by Andy Schmeltz, Global President, Oncology, and Chris Boshoff, Senior Vice President and Head, Immuno-Oncology, Early Development and Translational Oncology, at the Cowen and Company 38th Annual Healthcare Conference

 
- Dan R. Littman Elected to Pfizer’s Board of Directors

Pfizer Inc. today announced the election of Dr. Dan R. Littman to its Board of Directors. Dr. Littman, age 65, was also appointed to the Corporate Governance and Science and Technology Committees of Pfizer’s Board.

 

 
- Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF®

Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union (EU).

 
- Pfizer Announces Update on European Marketing Authorization Application for SUTENT® (sunitinib) in Adult Patients at High Risk of Recurrent Renal Cell Carcinoma

Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against expanding use of SUTENT® (sunitinib) to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney).

 
- Albert Bourla Elected to Pfizer’s Board of Directors

Pfizer Inc. today announced the election of Albert Bourla, DVM, Ph.D. to its Board of Directors, effective immediately.

Dr. Bourla, age 56, is currently the Chief Operating Officer (COO) of Pfizer.

 
- Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration . . .

 
- U.S., EU and Japan Health Authorities Accept Regulatory Submissions for Review of Pfizer’s Third-Generation ALK Inhibitor Lorlatinib

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational . . .

 
- Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. 

 
- Pfizer Reports Fourth-Quarter and Full-Year 2017 Results

Pfizer reported financial results for fourthquarter and full-year 2017 and provided 2018 financial guidance.

 
- Pfizer Announces Positive Top-Line Results For Potential Biosimilar To Rituxan®/MabThera®

Pfizer today announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US)/MabThera®1.

 
- Survey of Ulcerative Colitis Patients and Gastroenterologists Indicates that Symptoms May Create a New Reality for Patients

Pfizer announced today findings from the U.S. UC Narrative survey1,2 of ulcerative colitis (UC) patients and gastroenterologists (GIs).  The U.S. survey findings are an initial analysis of a subset of the UC Narrative global survey, which was developed with input from the Global UC Narrative Advisory Panel.1

 
- Pfizer Inc. Announces Expiration and Results of its Tender Offer for its 5.750 per cent. Notes due 2021 and Related Solicitation of Consents

Pfizer Inc. (NYSE:PFE) (“Pfizer”) today announced the expiration and results of its previously announced (i) offer to purchase for cash (the “Tender Offer”) any and all of its outstanding €2,000,000,000 5.750 per cent. 

 
- Pfizer Establishes New Partnering Model for Early-Stage Academic Research

Pfizer Inc. (NYSE:PFE) today announced the creation of the Innovative Target Exploration Network (ITEN), a new, early-stage partnering model that enables collaborative relationships with select academic institutions and principal investigators around the world, to identify research projects that have the potential to deliver novel therapeutic targets and mechanisms of action to underpin future drug discovery in core areas of interest to Pfizer.

 
- Sangamo and Pfizer announce collaboration for development of zinc finger protein gene therapy for ALS

Sangamo Therapeutics, Inc. (Nasdaq: SGMO) and Pfizer Inc. (NYSE: PFE) today announced a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene. 

 
- FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO™(ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets.

 
- FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA® (axitinib)* for treatment-naïve patients with advanced renal cell carcinoma (RCC).

 
- U.S. FDA Approves Pfizer’s BOSULIF® (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)

Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). 

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Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.

 

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