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FDA

Showing 15 posts of 1442 posts found.

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HHS Secretary Alex Azar accused of overruling FDA on COVID-19 test quality reviews

September 16, 2020
Research and Development COVID-19, FDA, US, USA

Allegations have emerged accusing US Health and Human Services Secretary Alex Azar of overruling the FDA over the review of …

News
china_v_0_1

Major vaccine manufacturers sign COVID-19 safety pledge

September 9, 2020
Research and Development CDC, FDA, anti vaxx, anti-vaxx, coronavirus vaccine

Nine vaccine manufactures have signed a pledge to uphold ethical standards while producing their treatments for COVID-19.  The companies involved …

News
genentech_web

Genetech scores sixth FDA approval in lung cancer with Gavreto

September 7, 2020
Sales and Marketing Cancer, FDA, Genentech, lung cancer

Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive …

News
fda_21

FDA rejects oleandrin as a dietary supplement, after being touted by major Trump ally as a coronavirus treatment

September 7, 2020
Sales and Marketing FDA, coronavirus, fda treatment

The FDA has rejected a submission from Phoenix Biotechnology to market oleandrin as a dietary supplement.  Phoenix Biotechnology submitted oleandrin …

News
fda_21

FDA approves Abbott’s rapid portable COVID-19 test

August 27, 2020
Research and Development Abbott, COVID-19, FDA, test

The FDA has given emergency clearance for Abbott’s portable COVID-19 test that it will sell for just $5.  The company’s …

News
remsss

Gilead says FDA could expand eligibility of coronavirus patients for remdesivir

August 24, 2020
Sales and Marketing FDA, Gilead

The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead.

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fda

FDA grants emergency authorisation for coronavirus plasma treatment

August 24, 2020
Sales and Marketing COVID-19, FDA, coronavirus

The FDA has issued an Emergency Use Authorization (EUA) for convalescent plasma to treat patients with COVID-19. The regulatory body …

News

NICE recommends combination treatment from Roche for certain lymphoma patients

August 21, 2020
Medical Communications FDA, FDA Approval

NICE has moved to recommend Roche’s Polivy (polatuzumab vedotin), when combined with rituximab and bendamustine, for the treatment of diffuse …

News
gilead-sciences

FDA turns down Gilead’s JAK inhibitor filgotinib in rheumatoid arthritis, endangering 2020 approval hopes

August 20, 2020
Research and Development, Sales and Marketing FDA, Gilead, filgotinib

Gilead’s JAK inhibitor filgotinib has been unexpectedly knocked back by the FDA as a therapy to treat moderately to severely …

News
biogen-idec-tecfidera-dimethyl-fumarate

Mylan secures first FDA approval for generic version of Biogen’s Tecfidera following patent dispute

August 20, 2020
Sales and Marketing Biogen, FDA, Mylan, generic, tecfidera

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is …

News
fda_21

FDA delays BioMarin’s gene therapy for haemophilia A

August 20, 2020
Research and Development, Sales and Marketing FDA

The FDA has delayed Roctavin, BioMarin’s gene therapy for haemophilia A, by a year to wait for more extensive results, …

News
fda2outsideweb

FDA panel votes 9-1 in favour of approval for Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease

August 14, 2020
Medical Communications, Sales and Marketing FDA, Mesoblast, Ryoncil, pharma

It’s good news for Mesoblast as an expert FDA panel gave a glowing recommendation for the approval in the US …

News

FDA approves NS Pharma’s Viltepso for Duchenne muscular dystrophy, but concerns over benefit persist

August 13, 2020
Sales and Marketing Duchenne Muscular Dystrophy, FDA, NS pharma, Viltepso

NS Pharma has claimed a tentative FDA approval for its Viltepso (viltolarsen) injection in the treatment of Duchenne muscular dystrophy …

News
fdaoutsideweb

Genentech’s Evrysdi becomes first FDA-approved oral treatment for spinal muscular atrophy

August 10, 2020
Sales and Marketing Evrysdi, FDA, Genentech, Roche, spinal muscular atrophy

Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy (SMA), making it the first oral therapy …

News
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Trump signs executive order to direct federal agencies to prioritise purchasing drugs made in the US

August 7, 2020
Manufacturing and Production, Medical Communications, Sales and Marketing FDA, Peter Navarro, Trump, drug prices

US President Donald Trump has signed an executive order which will direct federal agencies to prioritise buying drugs and drug …

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The Gateway to Local Adoption Series

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