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All announcements

Announcement Date

FDA Grants Second Approval for BAVENCIO (avelumab)


May 9, 2017- The U.S. Food and Drug administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc. and Pfizer Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this
May 9, 2017

Pfizer announces US FDA filing acceptance of supplemental new drug application for Xeljanz for the treatment of adult patients with active psoriatic arthritis

May 3, 2017

IBRANCE® (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer


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.
March 31, 2017

Pfizer announces FDA Approval of BAVENCIO (avelumab) Injection


March 23, 2017- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, 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 (MCC).
March 23, 2017

FDA approves Removal of Boxed Warning Regarding Serious Neuropsychiatric Events from Chantix (Varenicline) labeling.


Labeling revisions: removal of the Boxed warning from Chantix USPI. Please see the full press release via the link below for further details.
January 30, 2017

Alsuma has been discontinued from the market


Alsuma has been discontinued from the market. NDA withdrawal request for Alsuma was submitted to FDA in July 2016. Meridian Medical Technologies will no longer market or manufacture Alsuma.
January 10, 2017

New Medical Information Podcast on Duavee - Reports of breast cancer.


Listen to the New Medical Information Podcast on Duavee - Reports of breast cancer. Your browser does not support the audio element, see attachment instead.
May 11, 2016