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Showing 15 posts of 1442 posts found.

FDA approves AstraZeneca’s Calquence in chronic lymphoma

November 25, 2019
Sales 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 …

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fdaoutsideweb

FDA fast-tracks psilocybin treatment for major depressive disorder

November 25, 2019
Sales 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 …

News

Pfizer’s Humira biosimilar secures FDA approval, due to launch in 2023

November 18, 2019
Sales 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,   …

News

Shionogi gains US approval in complicated urinary tract infections with Fetroja

November 15, 2019
Medical 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), …

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fda2outsideweb

Label expansion of Amarin’s Vascepa has unanimous backing of FDA advisory panel

November 15, 2019
Medical 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 …

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fdaoutsideweb

Aveo backs off on tivozanib approval after FDA calls for more conclusive data

November 6, 2019
Research 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 …

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sandoz

Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection

November 6, 2019
Research 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 …

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flu_virus

FDA approves Sanofi’s quadrivalent flu vaccine for over-65s

November 6, 2019
Research 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 …

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fda2outsideweb

FDA approves RedHill Biopharma’s Talicia to combat Helicobacter pylori infection

November 4, 2019
Sales 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 …

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Donald Trump nominates Dr Stephen Hahn as next FDA Commissioner

November 4, 2019
Medical 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 …

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index

Catalyst’s lead candidate Firdapse falls short in Congenital Myasthenic Syndromes

October 31, 2019
Research 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 …

News

FDA committee votes to pull US approval for AMAG’s preterm birth drug Makena

October 31, 2019
Sales 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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FDA approves Biogen and Alkermes’ Vumerity for relapsing multiple sclerosis

October 30, 2019
Research and Development, Sales and Marketing Alkermes, Biogen, FDA, Vumerity, multiple sclerosis, pharma

The FDA has given the green light to Vumerity (diroximel fumarate), a novel oral fumarate developed by Biogen and Alkermes, …

News

FDA slams brakes on trial for world’s most expensive drug following safety concerns in children

October 30, 2019
Research and Development FDA, Novartis, Zolgensma, pharma

The FDA has temporarily shut down a clinical trial evaluating Zolgensma – the world’s most expensive drug at $3.1 million …

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vertex-headquarters

FDA approves Vertex’s Trikafta in new indication, now potentially covering 90% of cystic fibrosis patients

October 23, 2019
Research and Development, Sales and Marketing FDA, Trikafta, Vertex, cystic fibrosis, pharma

The FDA has granted marketing authorisation to Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF), it …

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