FDA - International Pharmaceutical Industry

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WuXi STA’s Jinshan Site Passes Fourth U.S. FDA Inspection

STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its Active Pharmaceutical Ingredient (API) manufacturing facility at...

26 July 2018 News FDA | fourth

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FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection

Acurx Pharmaceuticals, LLC ("Acurx" or the "Company"), a privately held clinical stage biopharmaceutical company focused on developing new antibiotics for difficul...

26 June 2018 News Acurx | antibiotic

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AbbVie slammed by FDA for improper handling of Humira death complaints: report

A number of AbbVie products coming out of its North Chicago, Illinois, manufacturing facility have been tied to death complaints, including its mammoth bl...

12 June 2018 News AbbVie | complaints

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FDA Announces Policies to Facilitate Development of Generic Drugs

Commissioner outlines new policies for drugs that have Risk Evaluation and Mitigation Strategy (REMS) requirements. In a recent statement, US Food and Drug Administr...

12 June 2018 News announces | development

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Genmab Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Newly Diagnosed Multiple Myeloma

DARZALEX (daratumumab) approved by U.S. FDA in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple mye...

8 May 2018 News announces | approval

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FDA approval for Novartis' melanoma combo

The FDA has approved Novartis' Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of BRAF V600E or V600K mutation-positiv...

1 May 2018 News approval | combo

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Uncategorised

FDA grants Keytruda priority review

The FDA has accepted for review Merck & Co's anti-PD-1 therapy Keytruda in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy (carbo...

1 May 2018 Uncategorised | News FDA | Keytruda

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News

TissueGene changes name to Kolon TissueGene, Inc.

By adding the name "Kolon," the new corporate identity recognizes the patient but committed support and effort by its parent company and major shareholder, the Kolon...

20 March 2018 News change | FDA

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U.S. FDA DEPUTY DIRECTOR LAWRENCE X. YU, PHD, TO PRESENT AT INTERPHEX 2018

International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical and biotechnology innovation, technology and knowledge from development ...

27 February 2018 News FDA | International pharmaceutical expo

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Phillips-Medisize Announces Expansion of Significant Medical Customer for Molex Little Rock Facility

Phillips-Medisize, a Molex company, announces the expansion of a significant medical customer for the Molex Little Rock facility. The long-time customer is a leader ...

23 January 2018 News cancer | detection

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