drug approval
Indian regulators approve first drug for patients with NASH
March 6, 2020Medical 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 …
Sanofi’s dengue vaccine scores 11th worldwide approval in Singapore
October 4, 2016Sales 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 …
Celgene says its Revlimid gets European approval to treat rare non-Hodgkin’s lymphoma
July 15, 2016Medical 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.
US FDA committee recommends approval for Amgen’s biosimilar of AbbVie’s Humira
July 13, 2016Research 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 …
Biogen and AbbVie’s Zinbryta gets European backing to treat multiple sclerosis
July 7, 2016Research 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 …
Gilead says US FDA approves Epclusa to treat hepatitis C
June 29, 2016Research 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 …
Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia
May 31, 2016Manufacturing 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 …
AstraZeneca’s COPD therapy gets US FDA approval
April 26, 2016Research 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 …
FDA approves Bayer haemophilia A drug Kovaltry
March 17, 2016Research 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 …
Drugs later in development ‘winning the race to market’
November 4, 2015Research 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 …
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