FDA
FDA steps in to prohibit codeine cough syrups for children
January 12, 2018Medical Communications FDA, biotech, drugs, pharma, pharmaceutical
The FDA has announced that it will require all labels to state that cough syrups containing codeine or hydrocodone are …
FDA approves shock wave wound healing device
January 2, 2018Manufacturing and Production, Sales and Marketing FDA, biotech, drugs, pharma, pharmaceutical
Continuing its recent trend to promote innovative new technologies, the FDA has announced that it has approved a medical device …
La Jolla Pharmaceutical scores FDA approval for blood pressure treatment
December 22, 2017Medical Communications, Sales and Marketing FDA, La Jolla pharmaceutical, blood pressure, pharma
The FDA has announced that it has approved La Jolla Pharmaceutical’s Giapreza (angiotensin II) injection for intravenous infusion to increase …
FDA grants breast cancer approval to Roche’s Perjeta/Herceptin combo therapy
December 21, 2017Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma
Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) …
Pfizer’s Bosulif scores US green light in leukaemia sub-type
December 21, 2017Sales and Marketing FDA, Pfizer, bosulif, leukaemia, leukemia, pharma
Pfizer has revealed that its tyrosine kinase inhibitor Bosulif (bosutinib) has been awarded marketing authorisation from the FDA in the …
FDA approves Pfizer’s Xeljanz for psoriatic arthritis
December 18, 2017Sales and Marketing FDA, Pfizer, Xeljanz, pharma, psoriatic arthritis
Pfizer has revealed that the FDA has passed marketing approval for Xeljanz (tofacitinib) for the treatment of active psoriatic arthritis …
Blood cancer patients over 75 are significantly underrepresented in clinical trials, study finds
December 13, 2017Research and Development FDA, blood cancer, leukaemia, lymphoma, myeloid leukaemia, pharma
The FDA’s first comprehensive analysis of clinical trial enrolment in older patients with blood cancers has revealed that the population …
FDA cracks down on snortable chocolate powder
December 13, 2017Medical Communications, Research and Development FDA, biotech, drugs, pharma, pharmaceutical
The FDA has taken action on Coco Loko and Legal Lean Syrup, both made by Arco Globus Trading LLC, after …
FDA approves first short-acting, follow-on biologic of Lilly’s Humalog insulin product
December 12, 2017Manufacturing and Production, Sales and Marketing Admelog, FDA, Humalog, Sanofi, diabetes, insulin, pharma
The FDA has announced its approval of Sanofi’s Admelog (insulin lispro), the first follow-on biologic version of Eli Lilly’s Humalog …
FDA issued the fewest warnings over pharma advertising this year since 1997
December 11, 2017Sales and Marketing Amherst, FDA, advertising, cipher, orexigen, pharma
Throughout 2017, it has emerged that the FDA has issued a record low number of warning letters to pharmaceutical firms …
FDA access programmes shaved up to a year off drug approval times, new study shows
December 7, 2017Research and Development, Sales and Marketing FDA, market access, pharma
A research letter published this week has suggested that the FDA initiatives to accelerate drug approvals in the US could …
Akili’s video game digital treatment shows promise in ADHD, eyes FDA approval
December 4, 2017Research and Development, Sales and Marketing ADHD, AKL-T01, Akili, FDA, pharma, video game
Akili, an unlisted affiliate of London-listed PureTech Health, has unveiled top-line results of AKL-T01, a novel digital medicine which takes …
Mylan’s Ogivri becomes first and only FDA-approved Herceptin biosimilar
December 4, 2017Sales and Marketing Biocon, Cancer, FDA, Herceptin, Mylan, Roche, biosimilar, pharma
The FDA has announced the approval of Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar version of Roche’s Herceptin to be authorised …
Gottlieb looking to approve cancer treatments on earlier evidence
December 1, 2017Medical Communications FDA, Scott Gottlieb, biotech, drugs, pharma, pharmaceutical
Scott Gottlieb, FDA commissioner, was speaking in front of the House Committee on Energy and Commerce, regarding the 21st Century …
FDA approves first and only therapy of its kind for opioid addiction
December 1, 2017Medical Communications, Sales and Marketing FDA, Invidior, Sublocade, US, opioid crisis, opioids, pharma
Image Credit: Marco VerchAs the US languishes in the midst of an opioid crisis which President Trump declared national emergency …
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