Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1442 posts found.

Tysabri image

Biogen and Elan file for Tysabri first line use in MS

January 18, 2013
Sales and Marketing Biogen IDEC, EMA, Elan, FDA, MS, Tsyabri, gilenya

Biogen Idec and Elan have applied to the FDA and EMA to expand Tysabri’s use in patients with relapsing forms …

News
FDA Hamburg image

FDA publishes guidance on abuse-resistant opioids

January 14, 2013
Manufacturing and Production CDC, FDA, hamburg, opioids

The US Food and Drug Administration has issued draft guidance designed to combat the escalating problem of abuse of prescription …

News
FDA image

FDA vote on J&J diabetes drug

January 10, 2013
Sales and Marketing EU, FDA, J&J, JJ, Janssen, canagliflozin

Key advisers to the FDA are meeting today to decide whether Janssen Pharmaceuticals’ type II diabetes drug canagliflozin is safe …

News
amgen image

$700m fines for Amgen

December 20, 2012
Manufacturing and Production, Sales and Marketing Amgen, FDA, off label, off-label

Amgen has pleaded guilty to misbranding its anaemia drug Aranesp following a string of US lawsuits against the biotech company. The …

News
Hospira image

Hospira downgraded as it recalls more sterile injectables

December 18, 2012
Manufacturing and Production FDA, Hospira

Generic pharma company Hospira’s efforts to bring its manufacturing network back into compliance took a knock this week when it …

News

US bill grants incentives to scarce drug producers

December 17, 2012
Manufacturing and Production FDA, PADSA

New legislation tabled in the US could provide incentives to companies producing drugs that are in short supply – particularly …

News
Protein image

Protein Sciences builds flu vaccine facility

December 6, 2012
Manufacturing and Production FDA, Protein

US drugmaker Protein Sciences has taken over a manufacturing facility formerly owned by Pfizer’s Wyeth unit as it prepares for …

News
Ranbaxy image

Ranbaxy suspends atorvastatin manufacturing after recall

November 30, 2012
Manufacturing and Production FDA, Ranbaxy, atorvastatin, recall

Ranbaxy Laboratories has called a halt to manufacturing its generic atorvastatin product until it can get to the bottom of …

News
Revolade image

GSK’s Promacta extends US licence

November 22, 2012
Sales and Marketing FDA, GSK, Promacta, Revolade

GlaxoSmithKline’s Promacta has received a new indication from the FDA which means it can be used for patients with thrombocytopenia …

News
Pfizer image

Pfizer in cystic fibrosis alliance

November 21, 2012
Research and Development, Sales and Marketing CFFT, CFTR, FDA, Pfizer

Pfizer and Cystic Fibrosis Foundation Therapeutics (CFFT) have signed a six-year pre-clinical deal to find new drugs to treat the …

News
Avastin image

Avastin shows brain cancer benefit

November 20, 2012
Research and Development, Sales and Marketing Cancer, FDA, Merck, Roche, avastin, brain

In a Phase III trial, Roche’s Avastin has helped people with newly-diagnosed glioblastoma (GBM) live longer without their disease worsening. …

News

Germany dismisses Seroquel XR

November 14, 2012
Sales and Marketing AstraZeneca, FDA, Germany, Seroquel XR

AstraZeneca has received another dent in its international attempts to keep the money-spinning antipsychotic Seroquel going in a new form. …

News
Xarelto image

Further US approval for Xarelto

November 5, 2012
Sales and Marketing Eliquis, FDA, Pradaxa, Xarelto

US regulators have given the go-ahead to expand the indications for which Janssen Pharmaceuticals and Bayer HealthCare’s oral blood thinner …

News
teva image

Teva’s CML drug approved

October 29, 2012
Research and Development, Sales and Marketing FDA, Synribo, Teva

Teva’s new treatment for chronic myeloid leukemia Synribo has been approved by the FDA. Synribo (omacetaxine mepesuccinate) is an injectable …

News
FDA image

Contaminated steroids blamed for deadly meningitis outbreak

October 25, 2012
Manufacturing and Production FDA, GMP, NECC

As many as 14,000 patients may have been exposed to contaminated steriods that have led to 23 deaths due to …

News
The Gateway to Local Adoption Series

Latest content

Just – Evotec given Gates Foundation grant to increase global biotherapeutics access

January 8, 2026

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026

EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

January 7, 2026

Eleva appoints Erich Rajkovic as Chief Business Officer

January 7, 2026

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026