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FDA ties three deaths to Edwards Lifesciences’ recalled heart devices

The U.S. Food and Drug Administration said three deaths were reported related to Edwards Lifesciences Corp.’s recall of some of the company’s heart devices.

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“Dueling Numbers”: FDA Panel Trying to Determine Safety of Paclitaxel-Coated Stents and Balloons

The U.S. FDA’s Circulatory System Devices Panel is undergoing two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons and paclitaxel-eluting stents.

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Abbott Launches First-ever Rapid Point-of-Care HbA1c Test to Aid in the Diagnosis of Diabetes

Abbott’s Afinion HbA1c Dx assay was launched as the only rapid point-of-care test cleared by the U.S. Food and Drug Administration to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients’ risk of developing the condition.

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FDA Approves Amgen and Allergan’s Kanjinti

Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.

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Many epinephrine self-injectors still potent long after expiration date

EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.

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FDA Approves First-Ever Indication for Device for Patients With Functional Abdominal Pain Associated With IBS

Innovative Health Solutions Inc. announced FDA clearance for the new device IB-Stim to treat functional abdominal pain associated with irritable bowel syndrome (IBS) in patients ages 11-18 years old.

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Abbott device helps in cutting blood sugar in type 2 diabetics: study

Insulin-dependent patients with T2D saw a significant drop in blood sugar levels after wearing Abbott’s continuous glucose monitoring system compared with those who use routine fingerstick testing.

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Medication-free treatment for depression launches in the UK

Flow, a medical device company, launched a medication-free treatment for depression comprising a brain stimulation headset and therapy app.

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FDA Approves NovoTTF-100L for Mesothelioma Therapy

The NovoTTF-100L therapy has become an FDA-approved therapy that is helping improve the lives of mesothelioma patients.

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FDA Approves NovoTTF-100LTM System

The U.S. FDA approved Novocure’s NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!


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