FDA
FDA gives priority review for AstraZeneca’s Imfinzi
November 29, 2019Medical Communications AstraZeneca, Cancer, FDA, Imfinzi, lung cancer
The FDA has granted a priority review of AstraZeneca’s cancer treatment drug Imfinzi (durvalumab) for treatment of patients with untreated …
FDA approves GBT’s Oxbryta to treat sickle cell disease
November 26, 2019Manufacturing and Production FDA, FDA Trump, Oxbryta, Sickle cell, sickle cell disease
The FDA announced yesterday that it has approved Global Blood Therapeutics’ marketing application for its haemoglobin polymerisation inhibitor Oxbryta, which …
US lawmakers call for FDA office in Israel
November 26, 2019Manufacturing and Production FDA, Golan Heights, Israel FDA, Netanyahu, Trump, USA, congress, israel
A bipartisan group of 21 US members of Congress has called for the establishment of an FDA office in Israel, …
FDA approves AstraZeneca’s Calquence in chronic lymphoma
November 25, 2019Sales and Marketing Astrazenaca, Calquence, FDA, Health Canada, leukaemia, oncology
The FDA has approved AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) in the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic …
FDA fast-tracks psilocybin treatment for major depressive disorder
November 25, 2019Sales and Marketing Controlled Substance Act, FDA, breakthrough therapy, major depressive disorder, psilocybin
The FDA has granted a Breakthrough Therapy designation to the Usona Institute for its trial use of psilocybin in the …
Pfizer’s Humira biosimilar secures FDA approval, due to launch in 2023
November 18, 2019Sales and Marketing Abrilada, FDA, Humira, Pfizer, biosimilar, pharma
Pfizer has confirmed the FDA approval of Abrilada (adalimumab-afzb), its biosimilar version of AbbVie’s Humira, the world’s best-selling drug, …
Shionogi gains US approval in complicated urinary tract infections with Fetroja
November 15, 2019Medical Communications, Sales and Marketing FDA, Fetroja, Shiogoni
Shionogi’s antibacterial therapy Fetroja (cefiderocol) has secured approval in the US for the treatment of complicated urinary tract infections (cUTI), …
Label expansion of Amarin’s Vascepa has unanimous backing of FDA advisory panel
November 15, 2019Medical Communications, Sales and Marketing Amarin, FDA, vascepa
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favour of expanding the existing approval of Irish …
Aveo backs off on tivozanib approval after FDA calls for more conclusive data
November 6, 2019Research and Development, Sales and Marketing Aveo Oncology, FDA, pharma
Aveo Oncology has hit another hurdle in its quest for approval of its vascular endothelial growth factor receptor tyrosine kinase …
Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection
November 6, 2019Research and Development, Sales and Marketing Amgen, FDA, Neulasta, Sandoz, Ziextenzo, pharma
The FDA has authorised the availability of Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar version of Amgen’s Neulasta, it has emerged. The …
FDA approves Sanofi’s quadrivalent flu vaccine for over-65s
November 6, 2019Research and Development, Sales and Marketing FDA, Fluzone, Sanofi, flu, influenza, pharma
Sanofi’s quadrivalent influenza vaccine Fluzone High Dose has secured FDA approval in adult patients over the age of 65 for …
FDA approves RedHill Biopharma’s Talicia to combat Helicobacter pylori infection
November 4, 2019Sales and Marketing FDA, RedHill Biopharma, pharma
RedHill Biopharma is celebrating after the FDA chose to award marketing authorisation to Talicia (omeprazole magnesium, amoxicillin and rifabutin) for …
Donald Trump nominates Dr Stephen Hahn as next FDA Commissioner
November 4, 2019Medical Communications, Sales and Marketing Donald Trump, FDA, Ned Sharpless, President trump, Scott Gottlieb, Trump, US
The US FDA could be set to receive its next long-term Commissioner after the White House revealed President Donald Trump’s …
Catalyst’s lead candidate Firdapse falls short in Congenital Myasthenic Syndromes
October 31, 2019Research and Development Catalyst Pharmaceuticals, FDA, firdapse, pharma, trial failure
Catalyst Pharmaceuticals has made it known that its lead product Firdapse (Amifampridine Phosphate) fell short of its primary endpoint in …
FDA committee votes to pull US approval for AMAG’s preterm birth drug Makena
October 31, 2019Sales and Marketing FDA, Makena, pharma
An FDA committee has passed a contentious vote recommending by a slim majority for the withdrawal of existing approval of …
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Five Facts about cardiovascular disease
