FDA
FDA approves Biogen and Alkermes’ Vumerity for relapsing multiple sclerosis
October 30, 2019Research 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, …
FDA slams brakes on trial for world’s most expensive drug following safety concerns in children
October 30, 2019Research 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 …
FDA approves Vertex’s Trikafta in new indication, now potentially covering 90% of cystic fibrosis patients
October 23, 2019Research 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 …
Porton Biopharma signs potential $24m deal to push its intranasal anthrax vaccine into Phase 1 trials
October 22, 2019Manufacturing and Production, Research and Development FDA, Porton Biopharma, anthrax, pharma
Porton Biopharma has signed a modification to its existing agreement with the US National Institute of Health’s National Institute of …
FDA approves Alexion’s Ultomiris in atypical haemolytic uremic syndrome for adults and children
October 21, 2019Sales and Marketing Alexion, FDA, Ultomiris, pharma, rare disease
The FDA has moved to expand the existing label for Alexion’s Ultomiris (ravulizumab-cwvz) to include the treatment of atypical haemolytic …
2019 saw the FDA approve more generic drugs than ever before
October 18, 2019Medical Communications, Sales and Marketing FDA, US, generic drugs, pharma
Fiscal year 2019 was a record-breaking one, according to the FDA. The US regulator smashed its previous total for annual …
FDA greenlights Genentech’s Xofluza for acute, uncomplicated influenza
October 18, 2019Medical Communications FDA, Genetech, Roche, US, Xofluza, flu, pharma
Roche subsidiary Genentech has announced that its polymerase acidic endonuclease inhibitor Xofluza (baloxavir marboxil) has been awarded FDA approval in …
FDA approves first and only transdermal patch for schizophrenia
October 16, 2019Research and Development, Sales and Marketing FDA, Noven Pharma, Secuado, US, pharma, schizophrenia
Hisamitsu Pharmaceutical subsidiary Noven Pharmaceuticals has revealed the FDA approval of Secuado (asenapine) in adult schizophrenia patients, making it the …
Lilly’s Reyvow becomes first FDA-approved 5-HT1F receptor agonist for acute migraine
October 15, 2019Manufacturing and Production, Sales and Marketing Eli Lilly, FDA, Reyvow, US, migraine, pharma
Eli Lilly has announced that the FDA has given the green light to Reyvow (lasmiditan) in the acute treatment of …
FDA approves Janssen’s Xarelto for blood clot prevention
October 15, 2019Manufacturing and Production, Sales and Marketing FDA, Janssen, US, Xarelto, pharma, thromboembolism
Janssen’s Xarelto (rivaroxaban) has secured FDA approval for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalised acutely …
FDA approves Pfenex’s osteoarthritis drug for patients at high risk of fracture
October 9, 2019Research and Development, Sales and Marketing FDA, Pfenex, osteoporosis, pharma
The FDA has awarded US approval to Pfenex’s drug PF708, it has emerged, as a treatment for osteoporosis in certain …
FDA approves Novartis’ Beovu injection for wet age-related macular degeneration
October 8, 2019Manufacturing and Production, Sales and Marketing Beovu, Eylea, FDA, Novartis, Regeneron, pharma
Novartis has secured FDA approval for its Beovu (brolucizumab) injection in the treatment of wet age-related macular degeneration (AMD), it …
FDA approves single-use auto-injector form of IL-5 inhibitor Fasenra
October 4, 2019Medical Communications, Sales and Marketing AstraZeneca, FDA, Fasenra, pharma
AstraZeneca is celebrating as the FDA announced the approval of its IL-5 inhibitor Fasenra (benralizumab) in a pre-filled, single-use auto-injector …
AbbVie’s Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients
September 27, 2019Medical Communications, Sales and Marketing AbbVie, FDA, hepatitis, hepatitis C, mavyret, pharma
The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the …
FDA approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma
September 27, 2019Medical Communications, Sales and Marketing FDA, Genmab, darzalex, pharma
Genmab’s CD38 inhibitor Darzalex (daratumumab) has been awarded marketing authorisation from the FDA in combination with bortezomib, thalidomide and dexamethasone …
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Five Facts about cardiovascular disease
