FDA Approval
FDA approves drug for primary biliary cholangitis
August 15, 2024Research and Development FDA Approval, FDA approva;, Hepatology, liver, primary biliary cholangitis
Accelerated approval has been granted for Gilead Science’s Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) by the US Food …
Avadel Pharmaceuticals granted FDA final approval for narcolepsy drug
May 3, 2023Medical 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, 2021FDA, 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, 2020Medical 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, 2020Business 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, 2020Medical 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, 2016Manufacturing 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 …
FDA approves GSK’s Votrient for new licence
April 30, 2012Sales 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, 2011Manufacturing 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, …
