FDA
FDA approves Caption Health’s AI-guided imaging system
February 10, 2020Sales and Marketing AI, Caption Health, FDA, ultrasound, ultrasound imaging
The FDA have given marketing approval for Caption Health’s Caption Guidance and its use in cardiac ultrasound images.The technology allows …
Seqirus’ Audenz becomes first FDA-approved cell-based adjuvant influenza A vaccine
February 5, 2020Research and Development, Sales and Marketing FDA, influenza, pharma, seqirus
The FDA has just approved the first adjuvanted, cell-based vaccine for the prevention of influenza A (H5N1) in the US, …
FDA approves first treatment for peanut allergy
February 3, 2020Sales and Marketing FDA, FDA Peanuts, peanut, peanut allergy, peanut medicine
The FDA has approved its first treatment for peanut allergy in patients between ages four and 17. The drug is …
FDA approves Teva’s Ajovy autoinjector for treatment of migraine
January 29, 2020Research and Development, Sales and Marketing FDA, Teva, ajovy, migraine, pharma
Israeli pharma firm Teva has revealed that the FDA has chosen to award approval to its autoinjector device for the …
FDA greenlights its first therapy for advanced epithelioid sarcoma population
January 27, 2020Sales and Marketing Cancer, Epizyme, FDA, Tazverik, pharma
The FDA has revealed the approval of its first therapy for the treatment of metastatic or locally advanced epithelioid sarcoma, …
FDA fast-tracks GSK’s multiple myeloma drug after priority review
January 22, 2020Research and Development BCMA, FDA, GSK, Phase 2 Trials, Phase Trials, multiple myeloma, myeloma
The FDA has fast tracked GlaxoSmithKline (GSK) antibody drug conjugate (ADC) belantamab mafodotin, for the treatment of patients with refractory …
Horizon’s Tepezza becomes first and only FDA-approved drug for thyroid eye disorder
January 22, 2020Research and Development FDA, Horizon Therapeutics, Tepezza, pharma
Horizon Therapeutics has announced that its IGF-1R inhibitor Tepezza (teprotumumab-trbw) has become the first and only therapy approved by the …
Lynparza secures accelerated FDA review for metastatic castration-resistant prostate cancer
January 20, 2020Sales and Marketing Cancer, FDA, lynparza, pharma
Following the recommendation of the tablet formulation of the drug for use on the NHS in England and Wales, news …
Top Ten most popular articles on Pharmafile.com this week
January 17, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Big Pharma, European Commission, FDA, Pakistan, Sanofi, Teva
Pakistan is cracking down on corruption and has registered cases against 200 pharmaceutical companies, while in the US the FDA …
Novo’s semaglutide injection and tablets get expanded FDA approval for type 2 diabetes with established CVD
January 17, 2020Medical Communications, Sales and Marketing FDA, Novo Nordisk, Ozempic, cardiovascular disease, diabetes, pharma
Novo Nordisk has seen label expansions approved from the FDA for both its glucagon-like peptide-1 (GLP-1) analogue injection Ozempic (once-weekly …
FDA approves Lannett’s cocaine-based nasal spray
January 15, 2020Research and Development FDA, Lannett, Numbrino, cocaine
It has been announced that the FDA has moved to approve Lannett Company’s Numbrino (cocaine hydrochloride) nasal solution for “the …
FDA approves Astellas injectable antifungal drug for newborns
January 13, 2020Sales and Marketing Astellas, Atellas Pharma, FDA, fungal virsus
The FDA has approved the first antifungal drug to specifically treat invasive candidiasis in newborns. From Astellas, the new drug …
Idorsia reveals it is working with Neurocrine on new epilepsy drug deal
January 10, 2020Medical Communications FDA, Idorsia, Neurocrine, drugs, epilepsy, pharma
Idorsia revealed its 2019 deal for its investigational epilepsy medicine was with Neurocrine Biosciences, and it is potentially worth more …
FDA approves alternative approach for Abbot HeartMate 3 heart pump
January 8, 2020Research and Development Abbott, FDA, Heart Pump, US Pharma, heart disease
The FDA announced today that it has approved a new alternative surgical technique for Abbot’s HeartMate 3 heart pump. The …
AstraZeneca’s drug Lokelma approved in China
January 6, 2020Sales and Marketing AstraZeneca, China, FDA, eu commission, kidney failure, potassium
AstraZeneca’s Lokelma has been approved by the National Medical Products Administration in China. This is due to positive results based …
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Five Facts about cardiovascular disease
