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On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs [...]

ROCKVILLE, MD -- The following information was released by the Regulatory Affairs Professionals Society: By Michael Mezher In its second enforcement letter of 2021, the US Food and Drug Administration's [...]

SILVER SPRING, MD -- The following information was released by the U.S. Food and Drug Administration (FDA): The Food and Drug Administration (FDA) has issued an untitled letter to Amgen [...]

NEW YORK, Sep 08, 2020 (GLOBE NEWSWIRE via COMTEX) -- - FDA Breakthrough Designation for CIN Indication: Plinabulin for Concurrent Administration with Myelosuppressive Chemotherapeutic Regimens in Patients with Non-Myeloid Malignancies [...]

ENPNewswire-June 12, 2020--FDA Approves Pfizer's Oncology Supportive Care Biosimilar, NYVEPRIA, pegfilgrastim-apgf (C)2020 ENPublishing - http://www.enpublishing.co.uk Release date- 11062020 - NEW YORK - Pfizer Inc. (NYSE: PFE) today announced the United [...]

ENPNewswire-May 28, 2020--FDA Accepts for Review Fresenius Kabi's BLA Submission for Pegfilgrastim Biosimilar (C)2020 ENPublishing - http://www.enpublishing.co.uk Release date- 27052020 - LAKE ZURICH - Fresenius Kabi, a global health care [...]

ENPNewswire-May 28, 2020--FDA accepts for review Fresenius Kabi's first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim (C)2020 ENPublishing - http://www.enpublishing.co.uk Release date- 27052020 - Fresenius Kabi, a [...]

NEW YORK, April 30, Apr 30, 2020 (GLOBE NEWSWIRE via COMTEX) -- - FDA Submission to Change the Primary Endpoint for Study 106 Phase 3 into an Industry First and [...]

A potential competitor to existing drugs used to treat low blood counts and infections due to chemotherapy will have its day at the Food and Drug Administration. However, the data [...]

ROCKVILLE, MD -- The following information was released by the Regulatory Affairs Professionals Society: By Zachary Brennan The US Food and Drug Administration (FDA) on Tuesday approved Sandoz's Ziextenzo (pegfilgrastim-bmez), [...]

NEW YORK, April 30, Apr 30, 2019 (GLOBE NEWSWIRE via COMTEX) -- - Significant Clinical Data Generated for Plinabulin - - On Track to Submit New Drug Applications (NDAs) for [...]

California: Coherus BioSciences, Inc. has issued the following press release: Coherus BioSciences, Inc. (Nasdaq: CHRS), today reviewed corporate highlights and reported financial results for the quarter ended June 30, 2018. [...]

REDWOOD CITY, Calif., Aug 08, 2018 (GLOBE NEWSWIRE via COMTEX) -- Coherus BioSciences, Inc. (Nasdaq: CHRS), today reviewed corporate highlights and reported financial results for the quarter ended June 30, [...]

IRVING: Vizient, Inc. has issued the following press release: Vizient today applauds the U.S. Food and Drug Administration (FDA) on its announcement yesterday that it approved the first biosimilar to [...]

Biocon Ltd and partner Mylan NV on Tuesday announced the grant of approval by the US Food and Drug Administration (FDA) for their cancer drug Fulphila (pegfilgrastim-jmbd), a biosimilar to [...]

ENPNewswire-June 6, 2018--U.S. FDA Approves Mylan and Biocon's Fulphila, the First Biosimilar to Neulasta (C)2018 ENPublishing - http://www.enpublishing.co.uk Release date- 05062018 - HERTFORDSHIRE - Mylan N.V. (NASDAQ: MYL) and Biocon [...]

Mumbai: Indsec Securities & Finance Ltd has issued the following press release: Biocon Ltd. has said that the U.S. Food and Drug Administration (FDA) has approved Mylan's FulphilaTM (pegfilgrastim-jmbd), a [...]

IRVING, Texas -- Vizient today applauds the U.S. Food and Drug Administration (FDA) on its announcement yesterday that it approved the first biosimilar to Neulasta (pegfilgrastim) and the overall progress [...]

Netherlands: MYLAN N.V. has issued the following press release: Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration [...]

The Mylan-Biocon combine have notched up their second biosimilar in the United States following the regulatory approval given to Fulphila, Mylan`s biosimilar version of pegfilgrastim, originally sold by Amgen under [...]

Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection following myelosuppressive chemotherapy Mylan N.V. and [...]

Fulphila has been approved to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer Biocon and Mylan have received approval from US Food [...]

Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection following myelosuppressive chemotherapy Fulphila is the [...]

REDWOOD CITY, May 14, 2018 (GLOBE NEWSWIRE via COMTEX) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the U.S. Food and Drug Administration (FDA) has accepted and acknowledged for review the [...]

REDWOOD CITY, May 03, 2018 (GLOBE NEWSWIRE via COMTEX) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta(R)) biosimilar [...]

Rockville, MD -- The following information was released by the Regulatory Affairs Professionals Society: By Zachary Brennan 2016 and 2017 were difficult years for companies trying to win US Food [...]

The 'composition of matter' patent protecting Amgen Inc.`s (NASDAQ:AMGN) white-blood-cell-boosting drug Neulasta from competition has already expired. That may mean it`s only a matter of time before generic drug companies, [...]

REDWOOD CITY, Jun 12, 2017 (GLOBE NEWSWIRE via COMTEX) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the U.S. Food and Drug Administration ('FDA') has issued a complete response letter [...]

Canonsburg: Mylan N.V. has issued the following press release: Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug [...]

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for [...]

Amsterdam: Mylan N.V has issued the following news release: Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug [...]

Amsterdam: Mylan N.V has issued the following news release: HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Feb. 16, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: [...]

Second Successful BLA Filing of the Partnership in the U.S. HERTFORDSHIRE, England, PITTSBURGH and®BENGALURU, India, Feb. 16, 2017 /PRNewswire/ --®Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, [...]

2018 JUN 21 (VerticalNews) -- By a News Reporter-Staff News Editor at Politics & Government Business -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced [...]

M2 PHARMA-June 11, 2018-Vizient Applauds Recent Approval of First Neulasta Biosimilar by FDA (C)2018 M2 COMMUNICATIONS - Irving, Texas-based health care performance improvement company Vizient has commended the US Food [...]

M2 PHARMA-June 6, 2018-US Food and Drug Administration grants Myland and Biocon approval for Fulphila (C)2018 M2 COMMUNICATIONS The US Food and Drug Administration (FDA) has granted approval to US [...]

M2 EQUITYBITES-June 6, 2018-US Food and Drug Administration grants Myland and Biocon approval for Fulphila (C)2018 M2 COMMUNICATIONS http://www.m2.com The US Food and Drug Administration (FDA) has granted approval to [...]

Oct 11, 2016 (M2 EQUITYBITES via COMTEX) -- Biosimilar company Coherus BioSciences Inc (NasdaqGM:CHRS) stated on Thursday that it has successfully filed a 351(k) Biologics License Application for CHS-1701 with [...]

Redwood City: Coherus BioSciences, Inc. has issued the following press release: Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, today announced that the U.S. [...]

WASHINGTON -- The following information was released by the Department of Health and Human Services: As a part of its mission to help protect Americans' health following even the most [...]

Ontario, Canada: Apotex, Inc has issued the following news release: Apotex Inc., the largest Canadian owned pharmaceutical company, announced today that the US Food and Drug Administration has accepted for [...]

New Analysis From Phase 3 Trial of Kyprolis (Carfilzomib) Combination Treatment in Relapsed Multiple Myeloma Patients With Early Disease Progression Phase 1/3 MASTERKEY-265 Study Abstracts Present Data on IMLYGIC (Talimogene [...]