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Showing 15 posts of 1442 posts found.

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FDA places no penalties on Novartis after Zolgensma data manipulation investigation

April 2, 2020
Business Services FDA, Novartis, regulators

The FDA has concluded its investigation into Novartis and its data manipulation of the gene therapy Zolgensma, and has decided …

News
00000000_fda

FDA aims to accelerate COVID-19 therapies with new programme

April 1, 2020
Research and Development COVID-19, FDA, america, coronaviurs

The FDA has launched the Coronavirus Treatment Acceleration Program (CTAP) to quickly bring therapies and treatments to people suffering from …

News
astrazeneca_building_white

FDA immunotherapy first with the approval of AZ’s Imfinzi in first-line extensive-stage small cell lung cancer

March 30, 2020
Sales and Marketing AstraZeneca, Cancer, FDA, Imfinzi, lung cancer, pharma

AstraZeneca has seized FDA approval for its immune checkpoint inhibitor Imfinzi (durvalumab) in the first-line treatment of extensive-stage small cell …

News
mesa_biotech_accula

FDA invokes emergency powers to authorise 30-minute, handheld COVID-19 test

March 27, 2020
Medical Communications, Sales and Marketing COVID-19, FDA, Mesa Biotech, US, coronavirus

The FDA invoked Emergency Use Authorization powers to approve a rapid, handheld testing kit for COVID-19 coronavirus cases just days …

News
fda2outsideweb

FDA turns down label expansion for Jardiance as an adjunct to insulin in type 1 diabetes

March 23, 2020
Sales and Marketing FDA, diabetes, jardiance, pharma

The FDA has chosen not to approve an expanded indication of 2.5mg Jardiance (empaglifozin) as an adjunct to insulin in …

News

FDA gives emergency authorisation to first coronavirus tests

March 17, 2020
Manufacturing and Production, Sales and Marketing FDA, Roche, US, coronavirus

The coronavirus crisis in the US has thus far been characterised by a lack of testing within its population. This …

News
celltrion1

FDA greenlights Celltrion HIV drug manufacturing facility in South Korea

March 16, 2020
Manufacturing and Production, Sales and Marketing FDA, celltrion, coronavirus, pharma

South Korean biopharma firm Celltrion has revealed that one of its key manufacturing facilities has been given the all-clear by …

News
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Bristol-Myers Squibb liver cancer drug combo gets FDA approval

March 12, 2020
Business Services Bristol; Myer Squibb, FDA, FDA BSM, FDA approvals

The FDA announced on Wednesday that it approved Bristol-Myers Squibb’s Opdivo in combination with Yervoy to treat patients with hepatocellular …

News
fda2outsideweb

FDA halts overseas inspections over coronavirus concerns

March 11, 2020
Research and Development, Sales and Marketing FDA, US, approvals, pharma

The FDA has responded to the ongoing COVID-19 coronavirus outbreak by announcing that it will halt all inspections of overseas …

News
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Boehringer’s TKI inhibitor Ofev gets FDA approval for chronic fibrosing interstitial lung diseases with a progressive phenotype

March 10, 2020
Manufacturing and Production, Sales and Marketing Boehringer, FDA, ofev, pharma

The FDA has green-lit Boehringer Ingelheim’s multi-targeted tyrosine kinase inhibitor Ofev (nintedanib) in the treatment of chronic fibrosing interstitial lung …

News

FDA authorises first therapy to tackle cortisol overproduction in Cushing’s disease

March 9, 2020
Sales and Marketing Cushing's disease, FDA, pharma

The FDA has moved to approve its first therapy to directly treat the overproduction of the hormone cortisol which is …

News
martin_shkreli_2016

FDA approves first generic version of Shkreli-hiked toxoplasmosis drug Daraprim

March 2, 2020
Sales and Marketing Cerovene, Daraprim, FDA, Martin Shkreli, generics, pharma

The FDA has awarded approval to the first generic medicine for the treatment of toxoplasmosis, authorising Cerovene’s version of Daraprim …

News
fda2outsideweb

Acacia Pharma secures first FDA approval with Barhemsys for postoperative nausea and vomiting

February 28, 2020
Medical Communications, Sales and Marketing Acacia, FDA, UK, US, pharma

UK-based Acacia Pharma has secured its first US approval with the FDA’s decision to authorise Barhemsys (amisulpride injection) for the …

News
lilly_entrance_web

FDA advisory committee narrowly backs Eli Lilly’s Cyramza combo for metastatic EGFR+ NSCLC

February 27, 2020
Sales and Marketing Eli Lilly, FDA, cyramza, pharms

Eli Lilly’s Cyramza (ramucirumab) has edged closer to US approval after it scored a recommendation from the FDA’s Oncologic Drugs …

News

Female participation up in 2019 US clinical trials, but minority representation down

February 27, 2020
Medical Communications, Research and Development FDA, clinical trials, pharma

The FDA’s Drugs Trials Snapshots 2019 report has been released, clarifying the demographic distribution of participants who were included in …

News
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