FDA
FDA approval for BMS and Acceleron’s Reblozyl to reduce red blood cell transfusion dependence
April 6, 2020Manufacturing and Production, Sales and Marketing BMS, FDA, Reblozyl, pharma
The FDA has given the regulatory thumbs-up in the US of Reblozyl (luspatercept-aamt), the “first and only erythroid maturation agent” …
FDA calls for heartburn drug Zantac to be pulled due to carcinogen concerns
April 2, 2020Business Services FDA, NDMA, Sanofi, heartburn
The FDA is requesting that manufactures remove Zantac (ranitidine) from the market due to risks of it containing a carcinogen. …
US approval for haemophilia drug derived from genetically engineered rabbit’s milk
April 2, 2020Sales and Marketing FDA, US, haemophilia, pharma
The FDA has announced the approval of Sevenfact, a haemophilia therapy the active ingredient from which is expressed in genetically …
FDA places no penalties on Novartis after Zolgensma data manipulation investigation
April 2, 2020Business Services FDA, Novartis, regulators
The FDA has concluded its investigation into Novartis and its data manipulation of the gene therapy Zolgensma, and has decided …
FDA aims to accelerate COVID-19 therapies with new programme
April 1, 2020Research and Development COVID-19, FDA, america, coronaviurs
The FDA has launched the Coronavirus Treatment Acceleration Program (CTAP) to quickly bring therapies and treatments to people suffering from …
FDA immunotherapy first with the approval of AZ’s Imfinzi in first-line extensive-stage small cell lung cancer
March 30, 2020Sales and Marketing AstraZeneca, Cancer, FDA, Imfinzi, lung cancer, pharma
AstraZeneca has seized FDA approval for its immune checkpoint inhibitor Imfinzi (durvalumab) in the first-line treatment of extensive-stage small cell …
FDA invokes emergency powers to authorise 30-minute, handheld COVID-19 test
March 27, 2020Medical Communications, Sales and Marketing COVID-19, FDA, Mesa Biotech, US, coronavirus
The FDA invoked Emergency Use Authorization powers to approve a rapid, handheld testing kit for COVID-19 coronavirus cases just days …
FDA turns down label expansion for Jardiance as an adjunct to insulin in type 1 diabetes
March 23, 2020Sales and Marketing FDA, diabetes, jardiance, pharma
The FDA has chosen not to approve an expanded indication of 2.5mg Jardiance (empaglifozin) as an adjunct to insulin in …
FDA gives emergency authorisation to first coronavirus tests
March 17, 2020Manufacturing and Production, Sales and Marketing FDA, Roche, US, coronavirus
The coronavirus crisis in the US has thus far been characterised by a lack of testing within its population. This …
FDA greenlights Celltrion HIV drug manufacturing facility in South Korea
March 16, 2020Manufacturing and Production, Sales and Marketing FDA, celltrion, coronavirus, pharma
South Korean biopharma firm Celltrion has revealed that one of its key manufacturing facilities has been given the all-clear by …
Bristol-Myers Squibb liver cancer drug combo gets FDA approval
March 12, 2020Business Services Bristol; Myer Squibb, FDA, FDA BSM, FDA approvals
The FDA announced on Wednesday that it approved Bristol-Myers Squibb’s Opdivo in combination with Yervoy to treat patients with hepatocellular …
FDA halts overseas inspections over coronavirus concerns
March 11, 2020Research and Development, Sales and Marketing FDA, US, approvals, pharma
The FDA has responded to the ongoing COVID-19 coronavirus outbreak by announcing that it will halt all inspections of overseas …
Boehringer’s TKI inhibitor Ofev gets FDA approval for chronic fibrosing interstitial lung diseases with a progressive phenotype
March 10, 2020Manufacturing and Production, Sales and Marketing Boehringer, FDA, ofev, pharma
The FDA has green-lit Boehringer Ingelheim’s multi-targeted tyrosine kinase inhibitor Ofev (nintedanib) in the treatment of chronic fibrosing interstitial lung …
FDA authorises first therapy to tackle cortisol overproduction in Cushing’s disease
March 9, 2020Sales and Marketing Cushing's disease, FDA, pharma
The FDA has moved to approve its first therapy to directly treat the overproduction of the hormone cortisol which is …
FDA approves first generic version of Shkreli-hiked toxoplasmosis drug Daraprim
March 2, 2020Sales and Marketing Cerovene, Daraprim, FDA, Martin Shkreli, generics, pharma
The FDA has awarded approval to the first generic medicine for the treatment of toxoplasmosis, authorising Cerovene’s version of Daraprim …
