FDA Approval

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Avadel Pharmaceuticals granted FDA final approval for narcolepsy drug

May 3, 2023
Medical Communications FDA, FDA Approval, Neurology, avadel pharmaceuticals, narcolepsy, new drug approvals

Irish biopharmaceutical company Avadel Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted final approval and …

New Sanofi Sarclisa treatment for multiple myeloma approved by FDA

April 1, 2021
FDA, FDA Approval, Sanofi, Sarclisa, multiple myeloma

Sanofi’s Sarclisa drug has been approved by the FDA in combination with carfilzomib and dexamethasone (Kd) for the treatment of …

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 …


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.


Indian regulators approve first drug for patients with NASH

March 6, 2020
Medical Communications FDA Approval, India, Indian Pharma, drug approval

The Drug Controller General of India (DCGI) has approved the marketing application for Zydus Cadila’s saroglitazar to treat patients with …


Allergan launches Crestor generic in the US

May 3, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Allergan, AstraZeneca, Crestor, FDA, FDA Approval, cholesterol, generic, patent, patent expiry, sales

Allergan has received FDA approval on the generic version of AstraZeneca’s high cholesterol drug, Crestor (rosuvastatin), and has become the …

Votrient image

FDA approves GSK’s Votrient for new licence

April 30, 2012
Sales and Marketing Cancer, FDA Approval, GSK, Votrient

The FDA has approved GlaxoSmithKline’s cancer pill Votrient for the treatment of a rare group of cancers – but has …

Dechra Pharmaceuticals PLC FDA Approval for manufacturing at Dales Pharmaceuticals

December 9, 2011
Manufacturing and Production, Research and Development FDA Approval

Dechra® Pharmaceuticals PLCFDA APPROVAL FOR MANUFACTURING AT DALES® PHARMACEUTICALS  Dales Pharmaceuticals (‘Dales’ or the ‘Company’), based in Skipton, North Yorkshire, UK, …

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