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FDA

Showing 15 posts of 1442 posts found.

Spritam

First 3D-printed drug approved by FDA

August 4, 2015
Manufacturing and Production, Research and Development 3d printing, FDA, manufacturing, production

The world of medicine saw a new pharma milestone this week, with the first approval by the FDA of a …

News
Sanofi Regeneron

FDA and EMA approve heart drug Praluent

July 27, 2015
Sales and Marketing EMA, FDA, PCSK9, Regeneron, Sanofi, high cholesterol, praluent

The FDA and the EMA have both approved Sanofi and Regeneron’s new high cholesterol drug Praluent. Regulators on both sides …

News
FDA

FDA bans drug imports from Indian plant

July 21, 2015
Manufacturing and Production Emcure, FDA, GMP, Good Manufacturing Practices, India, compliance, manufacturing, production, safety

The FDA has blocked US imports from the manufacturing plants of a major Indian pharmaceutical firm over safety fears. The …

News
AstraZeneca

AstraZeneca receives US approval for Iressa

July 16, 2015
Medical Communications, Sales and Marketing AstraZeneca, FDA, Iressa, lung cancer, non-small cell lung cancer

AstraZeneca’s lung cancer therapy Iressa has been approved by the FDA – four years after the company pulled it from the …

News
Rexulti (brexpiprazole)

FDA approves Lundbeck and Otsuka’s Rexulti for depression

July 14, 2015
Sales and Marketing FDA, Lundbeck, Otsuka, Rexulti, US, brexpiprazole, depression, major depressive disorder, schizophrenia

Lundbeck and Otsuka have gained a yes vote from the FDA for their jointly-marketed antidepressant, Rexulti. The US regulator approved …

News
package_of_lutera_birth_control_pills

Actavis contraceptives recalled after packaging errors

July 9, 2015
Manufacturing and Production Actavis, FDA, manufacturing, packaging, product recall, production, recalls

Actavis is voluntarily recalling more than half a million boxes of contraceptive pills in the United States due to problems …

News
Novartis image

Novartis wins US nod for new heart drug

July 8, 2015
Research and Development, Sales and Marketing Entestro, FDA, LCZ696, Novartis, ejection fraction, heart failure, reduced ejection fraction, sacubitril

The FDA has given the green light to Novartis’ new heart failure drug, six weeks ahead of the scheduled date …

News
Vertex logo

Vertex’s cystic fibrosis drug gets FDA approval

July 3, 2015
Research and Development, Sales and Marketing FDA, Orkambi, Vertex, cystic fibrosis, gene therapy

Vertex Pharmaceuticals cystic-fibrosis drug Orkambi, which could treat as many as 8,500 patients in the US, has been approved by …

News
FDA image

FDA sued over failure to disclose Sovaldi data

June 30, 2015
Sales and Marketing FDA, Gilead, hepatitis C, sofosbuvir, sovaldi

Two groups that campaign for wider access to medicines have filed a lawsuit against the FDA, in a bid to …

News
Eisai image

Eisai earns FDA nod for Fycompa

June 22, 2015
Sales and Marketing Eisai, FDA, Fycompa

The FDA has expanded the patient groups for whom Eisai’s epilepsy drug Fycompa is available to include people who have …

News
FDA image

FDA links with PatientsLikeMe

June 16, 2015
Medical Communications, Sales and Marketing FDA, PatientsLikeMe, data

The US Food and Drug Administration has signed a research deal with PatientsLikeMe in a move the online patient network …

News
Hetlioz image

Consumer watchdog highlights FDA failures

June 15, 2015
Manufacturing and Production, Research and Development, Sales and Marketing FDA, brett wells, hetlioz, public citizen

Consumer watchdog Public Citizen has criticised the FDA for incorrectly expanding the use of Vanda Pharma’s sleep disorder drug Hetlioz …

News

Amgen and Novartis tussle over biosimilar injunction

June 4, 2015
Sales and Marketing Amgen, FDA, Neupogen, Novartis

Novartis has begun its court battle with Amgen over its biosimilar of cancer drug Neupogen, which Amgen is trying to …

News
Sprout image

FDA to assess female libido drug

June 4, 2015
Sales and Marketing FDA, Sprout Pharmaceutical, flibanserin, libido

The FDA is inching closer to a historic approval of a drug in the US commonly dubbed ‘Viagra for women’. …

News
Pfizer image

Pfizer gets first approval for rare lung disease

May 29, 2015
Sales and Marketing FDA, Pfizer, Rapamune, lung disease

Pfizer’s Rapamune will become the first drug available to treat the very rare lung disease lymphangioleiomyomatosis (LAM) after receiving approval …

News
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