FDA

Showing 15 posts of 1442 posts found.

FDA approves Agios’ oral leukaemia treatment Tibsovo

July 23, 2018
Sales and Marketing FDA, agios, approval, pharmaceuticals, tibsovo

The oral leukaemia treatment Tibsovo (ivosidenib) produced by Massachusetts-based Agios Pharmaceuticals has been approved for treatment of adult patients with …

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FDA approves Pfizer biosimilar version of Amgen’s Neupogen

July 23, 2018
Sales and Marketing Amgen, FDA, Neupogen, Nivestym, Pfizer, pharma

The FDA has announced its decision to approve Pfizer’s Nivestym, the firm’s biosimilar version of Amgen’s Neupogen (filgrastim), for use …

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Researchers successfully minimise diabetes drug side-effects in animal models

July 17, 2018
Manufacturing and Production, Research and Development FDA, diabetes, pharma, type 2 diabetes

Researchers at the University of Pennsylvania and Syracuse University have modified a key ingredient of current diabetes drugs to produce …

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FDA cautions consumers on fake warning letter scam

July 17, 2018
Manufacturing and Production FDA, fake, letter, scam, warning

The FDA has warned that criminals have been targeting customers who bought medicines online or over the phone with “official-looking, …

FDA expands Pfizer and Astellas’ Xtandi into castration-resistant prostate cancer

July 16, 2018
Sales and Marketing Astellas, Cancer, FDA, Pfizer, US, Xtandi, pharma, prostate cancer

Astellas and Pfizer have revealed that their androgen receptor inhibitor Xtandi (enzalutamide) has received approval from the FDA to expand …

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FDA approves first smallpox therapy to defend against bioterrorism

July 16, 2018
Sales and Marketing FDA, pharma, smallpox

The FDA has announced that it has awarded marketing authorisation to SIGA Technologies’ TPOXX (tecovirimat) in the first approval of …

AbbVie and Janssen announce failure of cancer drug Imbruvica in Phase 3 trial

July 12, 2018
Research and Development AbbVie, Cancer, FDA, Janssen, approval

AbbVie and Janssen have announced that Imbruvica (ibrutinib) failed to achieve the primary endpoint in a late-stage study assessing its …

Cadila scores FDA approval for BMS and Alvogen generics

July 3, 2018
Manufacturing and Production, Sales and Marketing Adolat, Alvogen, Bristol-Myers Squibb, Cadila, FDA, Questran, generics, pharma

Cadila Healthcare has announced that it has gained FDA final approval to market nifedipine ER tablets in the strengths of …

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GW Pharma’s Epidiolex becomes first cannabis-based medicine available in US

June 26, 2018
Manufacturing and Production, Sales and Marketing FDA, GW Pharma, Lennox-Gastaut syndrome, UK, US, cannabidiol, cannabis

In what could prove to be a pivotal decision, UK biotech GW Pharmaceuticals has announced that its oral cannabidiol solution …

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FDA approves first continuous glucose monitoring system

June 22, 2018
Medical Communications, Sales and Marketing FDA, diabetes, pharma

The US Food and Drug Administration (FDA) has approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people …

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Facebook unveils new feature to battle opioid crisis

June 20, 2018
Medical Communications, Research and Development, Sales and Marketing FDA, Facebook, US, opioid crisis, opioids, pharma

Despite its highly-publicised transgressions recently, tech giant Facebook is looking to do the right thing by wading into the ongoing …

FDA places hold on Ziopharm CAR-T trial

June 19, 2018
Manufacturing and Production, Research and Development CAR-T, FDA, pharma, ziopharm

CAR-T is emerging as one of the most potentially exciting therapies in the industry, particularly as a beacon for the …

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FDA rejects Valeant plaque psoriasis lotion over pharmacokinetic concerns

June 19, 2018
Manufacturing and Production, Sales and Marketing FDA, Valeant, pharma, psoriasis

Beleaguered pharma firm Valeant has come up against another bump in the road as its plaque psoriasis lotion Duobrii (halobetasol …

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Dr Reddy’s just-approved opioid dependence generic blocked over US patent dispute

June 18, 2018
Sales and Marketing Dr Reddy's, FDA, Mylan, US, opioid crisis, opioid dependence, opioids, suboxone

Dr Reddy’s Laboratories has taken two steps forward an one step back after its generic version of Suboxone Film (buprenorphine/naloxone) …

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FDA knocks back Mylan’s Advair generic for second time

June 14, 2018
Sales and Marketing Advair, FDA, GSK, Mylan, pharma

The FDA has rejected Mylan’s generic version of GlaxoSmithKline’s Advair for the second time following its knockback last year, citing …

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