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FDA

Showing 15 posts of 1442 posts found.

Does Trump pose a threat to the FDA’s future?

February 27, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump

President Trump’s first month in office made headlines across the industry just as it did in the wider media. Promises …

Feature
pharmafocus_march_cover

The March 2017 issue of Pharmafocus is now live!

February 22, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Actelion, FDA, Johnson & Johnson, MSD, Roche, Trump, crispr, immunotherapy, opdivo

The latest edition of Pharmafocus is available to read online now! From breakthroughs in antibiotic resistance R&D to gene editing …

News

FDA Priority Review for Pfizer investigational leukaemia drug

February 22, 2017
Research and Development, Sales and Marketing EMA, FDA, Inotuzumab ozogamicin, Pfizer, priority review

Pfizer has announced that its leukaemia treatment inotuzumab ozogamicin has been accepted for Priority Review by the US Food and …

News
naloxone

FDA rejects Amphastar’s application for NDA for intranasal overdose treatment

February 21, 2017
Research and Development Amphastar, FDA

Amphastar has received a Complete Response Letter (CRL) for its New Drug Application (NDA) for an intranasal version of Naloxone, …

News

Zydus Cadila scores twin FDA approvals

February 17, 2017
Medical Communications, Sales and Marketing FDA, Zydus Cadila

Indian pharmaceutical firm Zydus Cadila has announced that the US Food and Drug Administration (FDA) has given the go-ahead for …

News
lavalbldg1806696_853705

FDA approves Valeant plaque psoriasis drug despite suicide concerns

February 16, 2017
Sales and Marketing FDA, Siliq, Valeant, psoriasis

The US Food and Drug Administration (FDA) has announced that it has approved Valeant Pharmaceutical’s injectable psoriasis treatment Siliq (brodalumab) …

News
allergan

Allergan set to bolster ‘medical aesthetics’ unit with $2.5 billion Zeltiq deal

February 13, 2017
Manufacturing and Production, Sales and Marketing Allergan, FDA, Zeltiq

Allergan, the owner of Botox, has expanded its stake in the ‘medical aesthetics’ business by acquiring Zeltiq Aesthetics. Zeltiq has …

News
fda2outsideweb

FDA approves first treatment for Duchenne muscular dystrophy

February 10, 2017
Medical Communications, Sales and Marketing Duchenne Muscular Dystrophy, FDA, marathon, marathon pharmaceuticals

The FDA has announced that it has approved Emflaza (deflazacort), developed by Marathon Pharmaceuticals. The treatment will arrive on the …

News
fda2outsideweb

Italian firm warned by FDA over record-shredding and drug quality misrepresentation

February 1, 2017
Manufacturing and Production, Research and Development FACTA Farmaceutici, FDA

Italian drug manufacturer FACTA Farmaceutici has been issued a warning letter by the FDA after being found shredding “critical laboratory …

News

Trump’s “one in, two out” regulatory order threatens FDA, Obama Cures Act

January 31, 2017
Manufacturing and Production, Sales and Marketing FDA, Trump

An executive order signed by President Donald Trump on Monday has caused concern in the US pharma industry and beyond …

News

Indian pharma firm caught shredding documents at 1am by FDA

January 24, 2017
Manufacturing and Production, Research and Development FDA, Hetero Labs, observations

Hetero Labs, an Indian pharmaceutical firm, has been observed by the FDA shredding what the FDA judged to be controlled …

News
roche_close

Roche’s Actemra granted Priority Review by FDA

January 24, 2017
Manufacturing and Production, Sales and Marketing Actemra, FDA, Roche, priority review

Roche’s drug, Actemra (also known as RoActemra in Europe), has been granted priority review designation by the FDA for the …

News

J&J’s Imbruvica scores fifth FDA lymphoma approval

January 20, 2017
Medical Communications, Research and Development, Sales and Marketing FDA, Marginal Zone Lymphoma, imbruvica

Johnson & Johnson’s Imbruvica (ibrutinib) has scored its fifth indication approval in the US for the treatment of Marginal Zone …

News

IBM and FDA collaborate to protect patient data with blockchain technology

January 12, 2017
Medical Communications, Research and Development FDA, blockchain, blockchain technology, ibm

IBM Watson Health has agreed a research initiative with the FDA to develop and test the exchange of patients’ health …

News
biocon_office

Mylan and Biocon apply to FDA for biosimilar approval

January 12, 2017
Sales and Marketing Biocon, FDA, Mylan, biosimilar, trastuzumab

Mylan, the US-based generics specialist, and Biocon, an Indian biopharmaceutical company, have applied for a biologics license application (BLA) for …

News
The Gateway to Local Adoption Series

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