US FDA
Lawsuit against FDA claims Bernie Sanders played role in approval of rival drug
February 17, 2020Research and Development, Sales and Marketing Bernie, Bernie Sanders, Catalyst Pharmaceuticals, FDA, TRUMP FDA, US FDA
Catalyst Pharmaceutical is attempting to show in court that pressure from US Senator Bernie Sanders led to the approval of …
FDA approves Indian firm Alembic’s generic of Teva’s Diamox
February 20, 2019Research and Development ANDA, Alembic, Gujurat, US FDA, diamox, generics
The US FDA has approved Guajarati firm Alembic Pharmaceuticals generic version of Teva’s Acetazolamide sold under the brand name Diamox, …
Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review
July 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing Johnson & Johnson, US FDA, WHO, drug trial, new drug application, regulation, soil-transmitted helminthiasis
Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New …
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 …
US FDA lifts hold on Juno’s CAR-T therapy trials; shares jump
July 13, 2016Research and Development, Sales and Marketing Stock Price, US FDA, drug trial, juno therapeutics
Shares in Juno Therapeutics (Nasdaq: JUNO) jumped to close up almost 30% after the company said the US Food and …
AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor
July 11, 2016Sales and Marketing AstraZeneca, Crestor, US FDA, patent, regulation
Anglo-Swedish drug firm AstraZeneca (LSE: AZN) has filed a temporary restraining order to prevent the US Food and Drug Administration from …
US FDA approves Roche Cobas HPV Test
July 8, 2016Medical Communications, Research and Development HPV, Roche, US FDA, regulation
The US Food and Drug Administration (FDA) has approved cancer drugmaker Roche’s (VTX: ROG) cobas HPV Test. The first test …
Lundbeck, Otsuka’s trial Alzheimer’s disease drug gets US FDA fast track designation
July 8, 2016Medical Communications, Research and Development Alzheimer's disease, Lundbeck, Otsuka, US FDA, drug development, drug trial, fast track designation
H. Lundbeck A/S (CPH: LUN) and Otsuka Pharmaceutical said the US Food and Drug Administration (FDA) have granted Fast Track …
AbbVie’s Imbruvica secures fourth breakthrough therapy designation from US FDA
July 1, 2016Medical Communications, Research and Development, Sales and Marketing AbbVie, US FDA, drug trial, imbruvica
US pharma firm AbbVie (NYSE: ABBV) said the US Food and Drug Administration has granted Imbruvica a fourth breakthrough therapy …
Shire says Phase II trial for rare eye condition in premature infants fails
July 1, 2016Medical Communications, Research and Development Shire, US FDA, drug trial, rare eye condition in infants
Shire plc (LSE: SHP) said its drug compound to treat a rare eye condition in infants failed mid-stage trials. The …
Shire says trial drug for ADHD shows positive results
June 30, 2016Research and Development, Sales and Marketing ADHD, Shire, US FDA, drug trial, regulation
UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results. Philip …
Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold
June 29, 2016Research and Development, Sales and Marketing Regulus Therapeutics, US FDA, drug trial, hepatitis C virus, regulation
Shares in Regulus Therapeutics (Nasdaq: RGLS) plunged as much as 60% after the company said the US Food and Drug …
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 says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation
Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …
GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results
June 27, 2016Research and Development, Sales and Marketing Epidiolex, GW Pharmaceuticals, NDA, US FDA, drug trial, orphan drug
GW Pharmaceuticals (Nasdaq: GWPH) said late-stage trials for its Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut syndrome (LGS), a rare …
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