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Showing 15 posts of 1442 posts found.

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Aimmune’s peanut allergy therapy recommended for approval by FDA committee

September 16, 2019
Sales and Marketing Aimmune, FDA, peanut allergy, pharma

The FDA’s Allergenic Products Advisory Committee (APAC) has recommended the use of Aimmune Therapeutics’ AR101, also known by its proposed …

News
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Boehringer’s Ofev scores first-of-its-kind FDA approval in rare lung disease

September 10, 2019
Manufacturing and Production, Sales and Marketing Boehringer Ingelheim, FDA, US, lungs, ofev, pharma, rare disease

Boehringer Ingelheim’s Ofev (nintedanib) capsules have now secured marketing authorisation in the US, it has emerged, for the treatment of …

News
trump-fda

Trump’s FDA: Is the US regulator being steered by the President?

September 9, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump, US, drug safety, pharma

FDA activity has fallen under Donald Trump, with the number of warning letters issued by the regulator dropping by a …

Feature
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Cancer drugs have surged since the 80s to account for 1 in 4 FDA approvals, report reveals

September 5, 2019
Research and Development, Sales and Marketing Cancer, FDA, US, pharma

The number of cancer drug approvals in the US has surged over the last decade to account for over one …

News
mylan_building

Mylan gets provisional FDA greenlight for generic version of Lilly’s blockbuster cancer drug Alimta

September 2, 2019
Sales and Marketing Alimta, Cancer, Eli Lilly, FDA, Mylan, pharma

Mylan has scored a preliminary approval in the US from the FDA for its generic version of Eli Lilly’s blockbuster …

News
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FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

August 29, 2019
Medical Communications, Research and Development AbbVie, FDA, Gilead, HCV, MSD, hepatitis C, public health

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function …

News
alexion_solirispackaging

Alexion’s Soliris scoops up expanded EU approval in neuromyelitis optica spectrum disorder

August 28, 2019
Research and Development, Sales and Marketing Alexion, FDA, US, pharma, soliris

Alexion has announced the expanded EU approval of Soliris (eculizumab) as a treatment for neuromyelitis optica spectrum disorder (NMOSD) in …

News

Novartis exec pushed out over Zolgensma data scandal denies wrongdoing

August 21, 2019
Research and Development AveXis, FDA, Novartis, Zolgensma, data scandal, pharma, sma

Dr Brian Kaspar, the Novartis exec pushed out of AveXis over the Zolgensma data scandal, has said in a statement …

News

California man gets eight years in prison for falsely labelling erectile dysfunction drug

August 20, 2019
Manufacturing and Production FDA, erectile dysfunction, labellnig, pharma, tadalafil

A man from Walnut, California has been sentenced to eight years and four months in federal prison for illegally importing …

News
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FDA turns down Sarepta’s DMD drug over safety concerns

August 20, 2019
Manufacturing and Production DMD, FDA, approval safety, pharma, sarepta

The FDA has declined to approve Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug, citing safety concerns including risk of infection …

News
fda2outsideweb

FDA greenlights Nebriva’s Xenleta for community-acquired bacterial pneumonia

August 20, 2019
Manufacturing and Production, Sales and Marketing FDA, Nabriva, US, Xenleta, pharma, pneumonia

The FDA has awarded approval in the US to Nebriva Therapeutics’ Xenleta (lefamulin) for the treatment of adult patients with …

News
celgene_1_02

Celgene’s Inrebic becomes second FDA-approved therapy for rare bone marrow disorder

August 19, 2019
Sales and Marketing Cancer, Cerlgene, FDA, Inrebic, pharma, rare disease

Celgene is celebrating the approval in the US of its Janus kinase (JAK) 2 inhibitor Inrebic (fedratinib) in the treatment …

News
abbvie_0

AbbVie scoops up FDA approval for Rinvoq in moderately to severely active rheumatoid arthritis

August 19, 2019
Sales and Marketing AbbVie, FDA, Rinvoq, pharma, rheumatoid arthritis

The FDA has awarded marketing authorisation to AbbVie’s Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis, …

News

Pfizer recall two batches of migraine drug Relpax

August 16, 2019
Medical Communications FDA, Pfizer, Relpax, migraine, pharma, recall

Pfizer has recalled two lots of its migraine drug Relpax over concerns about microbiological contamination. In a statement on the …

News

FDA approve new drug for treatment-resistant TB

August 15, 2019
Research and Development FDA, TB, US, pharma, pretomanid, tuberculosis

The US FDA has approved BPaL, the TB Alliance’s treatment for drug-resistant tuberculosis (TB). The US regulator gave the go-ahead …

News
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