Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, IBRANCE® (palbociclib), based on the results from the confirmatory Phase 3 trial PALOMA-2. The FDA action converts the accelerated approval of IBRANCE to regular approval and broadens the range of anti-hormonal therapy that may be administered with IBRANCE.
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Press Release Archive
TRUMENBA Has Been Studied in a Global Clinical Development Program Evaluating the Vaccine in Adolescents and Adults
Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved under accelerated approval based on tumor response and duration of response.
Pfizer China announced today that it has received approval from the Chinese Food and Drug Administration (CFDA) to market its oral Janus kinase (JAK) inhibitor, XELJANZ
Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational New Drug (IND) clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.
Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Frank D’Amelio, Executive Vice President, Business Operations and Chief Financial Officer, at the Barclays Global Healthcare Conference on Wednesday, March 15, 2017 at 1:35 p.m. Eastern Daylight Time.
In conjunction with International Women’s Day, The Union for International Cancer Control (UICC) and Pfizer Inc. today announced the next phase of their pioneering grants initiative to address the unique challenges facing metastatic breast cancer (mBC) patients around the globe. The Seeding Progress and Resources for the Cancer Community (SPARC): Metastatic Breast Cancer Challenge was designed to support the implementation of projects that address the specific needs of women with metastatic breast cancer globally - many of which extend beyond treatment.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:FE), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose combination of ertugliflozin and JANUVIA® (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin.
Pfizer Inc. (NYSE:PFE) today announced the pricing of a debt offering consisting of four tranches of notes:
€1,250,000,000 aggregate principal amount of floating rate notes due 2019
€1,000,000,000 aggregate principal amount of 0.000% notes due 2020
€1,000,000,000 aggregate principal amount of 0.250% notes due 2022
€750,000,000 aggregate principal amount of 1.000% notes due 2027
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by John Young, Group President, Pfizer Essential Health, at the Cowen and Company 37th Annual Healthcare Conference on Tuesday, March 7, 2017 at 11:20 a.m. Eastern Standard Time. To view and listen to the webcast, visit our web site at www.pfizer.com and click on the “Cowen and Company 37th Annual Healthcare Conference” link in the For Investors section located on the lower right-hand corner of that page.
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab* as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2017, for avelumab in this indication.
Pfizer Inc. (NYSE: PFE) today announced the pricing of $1,065,000,000 aggregate principal amount of 4.20% notes due 2047. This offering is expected to besold to professional institutional investors in Taiwan, with application to be made to list the notes on the Taipei Exchange.
Pfizer intends to use the net offering proceeds for general corporate purposes, including to repay a portion of its outstanding commercial paper.
The closing of the offering is expected to occur on March 17, 2017, subject to satisfaction of customary closing conditions.
Pfizer Inc. today announced the election of Ronald E. Blaylock to its Board of Directors, effective immediately. Mr. Blaylock was also appointed to the Corporate Governance and Science and Technology Committees of Pfizer’s Board.
Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Data announced jointly today by Pfizer Inc.
Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint. There were three comparisons,which found:
Pfizer Inc. (NYSE:PFE) announced today that the U.S.
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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