FDA

Showing 15 posts of 1442 posts found.

Hikma’s Advair generic delayed in the US

March 12, 2018
Sales and Marketing Advair, FDA, GSK, GlaxoSmithKline, pharma

Hikma Pharmaceuticals has been knocked back with the news that the FDA has delayed approval of its generic lung treatment …

dengvaxia

Sanofi’s controversial dengue vaccine may still hit US market, despite Philippines disaster

March 7, 2018
Sales and Marketing FDA, Philippines, Sanofi, US, dengue, dengvaxia, pharma

Sanofi has revealed that the ongoing debacle in the Philippines concerning its dengue vaccine Dengvaxia has not deterred it from …

FDA authorises first direct-to-consumer test for BRCA mutations, with caveats

March 6, 2018
Research and Development, Sales and Marketing 23andME, BRCA, Cancer, FDA, breast cancer, ovarian cancer, pharma

The FDA has given its authorisation to the first ever direct-to-consumer (DTC) test to identify three BRCA gene mutations which …

FDA finds major manufacturing issues at key Aurobindo facility

March 5, 2018
Manufacturing and Production, Sales and Marketing Aurobindo, FDA, pharma

Indian pharmaceutical firm Aurobindo has been rocked by an USFDA review which identified nine major issues with its Unit 4 …

satu1028-pano_1024_px

EMA set to also revise guidelines of Alzheimer’s trials

February 28, 2018
Medical Communications Alzheimer's, EMA, FDA, biotech, drugs, pharma, pharmaceutical

The EMA, following on from the FDA’s lead earlier this month, has announced that it will revise its guidelines on …

celgene_1_02

FDA refuses to review Celgene’s ozanimod in multiple sclerosis

February 28, 2018
Research and Development, Sales and Marketing Celgene, FDA, multiple sclerosis, ozanimod, pharma

Celgene has been dealt a heavy blow, revealing that the FDA has rejected its New Drug Application for its sphingosine …

opioid_crisis

FDA to fight opioid crisis with wider access to medication-assisted treatment

February 27, 2018
Manufacturing and Production, Medical Communications, Research and Development Alex Azar, FDA, medication-assisted treatment, opioid crisis, opioids, pharma

The FDA is set to refocus its efforts in combating the United States’ opioid crisis. Speaking at a meeting of …

FDA expands indication of Lilly’s Verzenio in advanced breast cancer

February 27, 2018
Manufacturing and Production, Sales and Marketing Cancer, Eli Lilly, FDA, Verzenio, breast cancer, pharma

Eli Lilly is celebrating the news that its cyclin-dependent kinase (CDK) 4 & 6 inhibitor Verzenio (ademaciclib) has received approval …

regeneron

Reports increasing of worrying side-effects with Regeneron’s Eylea

February 22, 2018
Medical Communications, Research and Development, Sales and Marketing Eylea, FDA, Regeneron, pharma

Reports are emerging which detail some pretty alarming side-effects in patients receiving Regeneron’s blockbuster eye drug Eylea: once injected into …

fda_building_web

FDA weighs up divisive change to Alzheimer’s drug assessment

February 16, 2018
Medical Communications Alzheimer's, FDA, biotech, drugs, pharma, pharmaceutical

Alzheimer’s disease (AD) is an area badly in need of a treatment, the problem is that this prospect seems to …

jj

J&J’s apalutamide scores snap FDA approval in castration-resistant prostate cancer subgroup

February 15, 2018
Sales and Marketing Cancer, Erleada, FDA, J&J, JJ, Johsnon & Johnson, apalutamide, pharma, prostate cancer

Johnson & Johnson has announced that its androgen receptor inhibitor apalutamide, now branded as Erleada, has received approval from the …

FDA expands J&J Zytiga combo’s indication to include castration-sensitive prostate cancer

February 9, 2018
Medical Communications, Sales and Marketing Cancer, FDA, J&J, JJ, Janssen, Johnson & Johnson, Zytiga, pharma

Johnson & Johnson has announced that Zytiga (abiraterone acetate) in combination with prednisone has been awarded FDA approval in the …

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