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US FDA

Showing 15 posts of 44 posts found.

19199400883_6db786ce0d_b

Lawsuit against FDA claims Bernie Sanders played role in approval of rival drug

February 17, 2020
Research 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 …

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francesa

FDA approves Indian firm Alembic’s generic of Teva’s Diamox

February 20, 2019
Research 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, …

News
johnson_and_johnson_jj

Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review

July 14, 2016
Manufacturing 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 …

News
fda_logo-web

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 …

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junologo

US FDA lifts hold on Juno’s CAR-T therapy trials; shares jump

July 13, 2016
Research 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 …

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astrazeneca_sign_sky

AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor

July 11, 2016
Sales 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 …

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fda_logo-web

US FDA approves Roche Cobas HPV Test

July 8, 2016
Medical 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 …

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Lundbeck, Otsuka’s trial Alzheimer’s disease drug gets US FDA fast track designation

July 8, 2016
Medical 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 …

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abbvie_0

AbbVie’s Imbruvica secures fourth breakthrough therapy designation from US FDA

July 1, 2016
Medical 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 …

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shire_image

Shire says Phase II trial for rare eye condition in premature infants fails

July 1, 2016
Medical 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 …

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shire_image_4

Shire says trial drug for ADHD shows positive results

June 30, 2016
Research 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 …

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fda_building

Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold

June 29, 2016
Research 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 …

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 …

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Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis

June 28, 2016
Manufacturing 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 …

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gwpharma

GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results

June 27, 2016
Research 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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