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drug approval

Showing 10 posts of 10 posts found.

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Indian regulators approve first drug for patients with NASH

March 6, 2020
Medical Communications FDA Approval, India, Indian Pharma, drug approval

The Drug Controller General of India (DCGI) has approved the marketing application for Zydus Cadila’s saroglitazar to treat patients with …

News
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Sanofi’s dengue vaccine scores 11th worldwide approval in Singapore

October 4, 2016
Sales and Marketing Sanofi, dengue, drug approval

Sanofi Pasteur, the vaccines unit of the wider French firm, has announced that its dengue vaccine Dengvaxia has secured market …

News
celgene_1_02

Celgene says its Revlimid gets European approval to treat rare non-Hodgkin’s lymphoma

July 15, 2016
Medical Communications, Research and Development, Sales and Marketing Celgene, European Commission, Revlimid, drug approval, drug trial, oncology

Celgene (Nasdaq: CELG) said the European Commission (EC) has approved Revlimid (lenalidomide) to treat a rare form of non-Hodgkin’s lymphoma. 

News
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US FDA committee recommends approval for Amgen’s biosimilar of AbbVie’s Humira

July 13, 2016
Research and Development, Sales and Marketing AbbVie, Amgen, Humira, US FDA, biosimilar, drug approval, drug trial, inflammatory diseases, rheumatoid arthritis

One of the world’s bestselling drug may soon have competition in the US markets after the regulators backed a biosimilar …

News
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Biogen and AbbVie’s Zinbryta gets European backing to treat multiple sclerosis

July 7, 2016
Research and Development, Sales and Marketing Biogen, drug approval, european union, multiple sclerosis, zinbryta

Biogen (Nasdaq: BIIB) and Abbvie’s (NYSE: ABBV) once-monthly Zinbryta (daclizumab) has been approved in European Union for treatment of multiple …

News
gilead-sciences

Gilead says US FDA approves Epclusa to treat hepatitis C

June 29, 2016
Research and Development, Sales and Marketing Epclusa, Gilead, HCV, US FDA, drug approval, regulation

US drug firm Gilead Sciences (Nasdaq: GILD) said the US Food and Drug Administration has approved its Epclusa (sofosbuvir/velpatasvir), in …

News

Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia

May 31, 2016
Manufacturing and Production Roche, chronic lymphocytic leukaemia, drug approval, regulation

Swiss drugmaker Roche (SIX: ROG) on Tuesday said the European Commission (EC) has approved the subcutaneous (SC) formulation of its …

News
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AstraZeneca’s COPD therapy gets US FDA approval

April 26, 2016
Research and Development, Sales and Marketing AstraZeneca, COPD, US FDA, drug approval

UK drug firm AstraZeneca (LSE: AZN) said the US Food and Drug Administration has approved its therapy to treat chronic …

News
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FDA approves Bayer haemophilia A drug Kovaltry

March 17, 2016
Research and Development, Sales and Marketing Bayer, FDA, approval, drug, drug approval, haemophilia, haemophilia a, kovaltry, viii compound

Bayer (ETR:BAYN) has received approval from the US Food and Drug Administration (FDA) for Kovaltry (octocog alfa), an unmodified, full-length …

News
researchers examining test tube

Drugs later in development ‘winning the race to market’

November 4, 2015
Research and Development R&D, drug approval, drug development, market exclusivity

Nearly all later entrants to drug classes were in clinical testing or regulatory review before first-in-class approval, according to the …

News

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