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Showing 15 posts of 1445 posts found.

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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fdaoutsideweb

FDA gives nod for Monjuvi combo for second-line relapsed or refractory diffuse large B-cell lymphoma

August 3, 2020
Sales and Marketing FDA, Incyte, Monjuvi, morphosys, pharma

The FDA has awarded MorphoSys and Incyte US approval for their Fc-modified cytolytic CD19-targeting monoclonal antibody Monjuvi (tafasitamab-cxix), when used …

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fdaoutsideweb

Kite secures FDA approval for second CAR T therapy Tecartus in relapsed or refractory mantle cell lymphoma

July 27, 2020
Sales and Marketing CAR T, CAR-T, FDA, Gilead, kite pharma

Kite Pharma has chalked up another regulatory success for its parent company Gilead with the news that the FDA has …

News
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AstraZeneca secures accelerated FDA review for Farxiga for for CV death following heart attacks

July 17, 2020
Medical Communications, Research and Development, Sales and Marketing AstraZeneca, FDA, farxiga, fast track

AstraZeneca has made it known that Farxiga (dapagliflozin) has secured Fast Track Designation from the FDA for the reduction of …

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fda

FDA grants fast review for Bayer and MSD’s heart failure drug vericiguat

July 17, 2020
Medical Communications Bayer, FDA, MSD

The FDA has granted a fast Priority Review for Bayer and MSD’s heart failure drug vericiguat. This was based on …

News
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Jannsen’s Tremfya becomes first FDA-approved IL-23 inhibitor for active psoriatic arthritis

July 15, 2020
Research and Development, Sales and Marketing FDA, Jannsen, Tremfya, active psoriatic arthritis

Janssen has reported that its therapy Tremfya (guselkumab) has become the first selective interleukin (IL)-23 inhibitor approved by the FDA …

News
fdaoutsideweb

FDA committee backs GSK’s belantamab mafodotin in relapsed or refractory multiple myeloma

July 15, 2020
Research and Development, Sales and Marketing Cancer, FDA, GSK, multiple myeloma, pharma

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has moved to recommend the use of GlaxoSmithKline’s belantamab mafodotin, or GSK2857916 as …

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viiv

ViiV Healthcare secures FDA approval for Rukobia combo in multidrug-resistant HIV-1

July 6, 2020
Sales and Marketing FDA, HIV, ViiV Healthcare

ViiV Healthcare, the HIV specialist majority owned by GSK which also counts Shionogi and Pfizer among its shareholders, has secured …

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fda

FDA says COVID-19 vaccine would need to be at least 50% effective to be approved

July 1, 2020
Research and Development COVID-19, FDA, coronavirus

The FDA announced that any COVID-19 vaccine that gets approval must show that it is at least 50% more effective …

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roche

Roche’s Phesgo combo secures US approval for metastatic HER2-positive breast cancer

June 30, 2020
Manufacturing and Production, Sales and Marketing FDA, Phesgo, Roche, US, breast cancer

The FDA has awarded marketing authorisation in the US to Roche’s Phesgo, a combination of subcutaneously injected Herceptin (trastuzumab) with …

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fdaoutsideweb

FDA rejects Allergan’s Abicipar pegol for neovascular age-related macular degeneration over benefit/risk concerns

June 29, 2020
Sales and Marketing AbbVie, Allergan, FDA, pharma

The FDA has moved to reject Allergan’s vascular endothelial growth factor (VEGF) factor A inhibitor, Abicipar pegol, as treatment for …

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fda

New research highlights how biases play a role in FDA drug approvals

June 25, 2020
Business Services FDA, FDA Approval

A new study has highlighted how human biases affect the regulatory approval process of the FDA.

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fda

FDA approves Crysvita for treating tumour-induced osteomalacia

June 19, 2020
Medical Communications FDA, FDA approvals

The FDA has approved Crysvita (burosumabtwza) injection to treat patients over two years old with tumour-induced osteomalacia (TIO). This is …

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