FDA
FDA issues a warning against Benadryl TikTok challenge
September 28, 2020Medical Communications, Sales and Marketing Benadryl, FDA, TikTok
The FDA has released a warning following cases of teens filming themselves overdosing on the antihistamine Benadryl and uploading the …
Novartis’ Zolgensma hits regulatory hurdle after FDA asks to review another study
September 24, 2020Research and Development FDA
The FDA has requested an additional study in older children being treated with Novartis’ Zolgensma in the review process for …
‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study
September 24, 2020Sales and Marketing FDA, regulation, smart drugs
Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new …
HHS Secretary Alex Azar accused of overruling FDA on COVID-19 test quality reviews
September 16, 2020Research and Development COVID-19, FDA, US, USA
Allegations have emerged accusing US Health and Human Services Secretary Alex Azar of overruling the FDA over the review of …
Major vaccine manufacturers sign COVID-19 safety pledge
September 9, 2020Research and Development CDC, FDA, anti vaxx, anti-vaxx, coronavirus vaccine
Nine vaccine manufactures have signed a pledge to uphold ethical standards while producing their treatments for COVID-19. The companies involved …
Genetech scores sixth FDA approval in lung cancer with Gavreto
September 7, 2020Sales and Marketing Cancer, FDA, Genentech, lung cancer
Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive …
FDA rejects oleandrin as a dietary supplement, after being touted by major Trump ally as a coronavirus treatment
September 7, 2020Sales and Marketing FDA, coronavirus, fda treatment
The FDA has rejected a submission from Phoenix Biotechnology to market oleandrin as a dietary supplement. Phoenix Biotechnology submitted oleandrin …
FDA approves Abbott’s rapid portable COVID-19 test
August 27, 2020Research and Development Abbott, COVID-19, FDA, test
The FDA has given emergency clearance for Abbott’s portable COVID-19 test that it will sell for just $5. The company’s …
Gilead says FDA could expand eligibility of coronavirus patients for remdesivir
August 24, 2020Sales and Marketing FDA, Gilead
The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead.
FDA grants emergency authorisation for coronavirus plasma treatment
August 24, 2020Sales and Marketing COVID-19, FDA, coronavirus
The FDA has issued an Emergency Use Authorization (EUA) for convalescent plasma to treat patients with COVID-19. The regulatory body …
NICE recommends combination treatment from Roche for certain lymphoma patients
August 21, 2020Medical Communications FDA, FDA Approval
NICE has moved to recommend Roche’s Polivy (polatuzumab vedotin), when combined with rituximab and bendamustine, for the treatment of diffuse …
FDA turns down Gilead’s JAK inhibitor filgotinib in rheumatoid arthritis, endangering 2020 approval hopes
August 20, 2020Research and Development, Sales and Marketing FDA, Gilead, filgotinib
Gilead’s JAK inhibitor filgotinib has been unexpectedly knocked back by the FDA as a therapy to treat moderately to severely …
Mylan secures first FDA approval for generic version of Biogen’s Tecfidera following patent dispute
August 20, 2020Sales and Marketing Biogen, FDA, Mylan, generic, tecfidera
The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is …
FDA delays BioMarin’s gene therapy for haemophilia A
August 20, 2020Research and Development, Sales and Marketing FDA
The FDA has delayed Roctavin, BioMarin’s gene therapy for haemophilia A, by a year to wait for more extensive results, …
FDA panel votes 9-1 in favour of approval for Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease
August 14, 2020Medical Communications, Sales and Marketing FDA, Mesoblast, Ryoncil, pharma
It’s good news for Mesoblast as an expert FDA panel gave a glowing recommendation for the approval in the US …
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Five Facts about cardiovascular disease
