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First Antibiotic With New Mechanism of Action Approved in Almost 20 Years

The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.

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Shriners Hospitals for Children Announces New Medical Device for Scoliosis Treatment Approved by FDA

A new medical device for treating scoliosis – curvature of the spine – received FDA approval, providing an alternative that both corrects the curve and maintains flexibility in the spine.

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FDA Approves First Non-Controlled Substance Treatment for Narcolepsy

Harmony Biosciences snagged approval from the U.S. FDA for the company’s first commercial product, a treatment for narcolepsy.

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U.S. FDA approves TB Alliance’s treatment for drug-resistant tuberculosis

The U.S. Food and Drug Administration approved TB Alliance’s treatment for drug-resistant tuberculosis as part of a three-drug combination regimen called BPaL.

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Kala Pharmaceuticals Receives FDA CRL for KPI-121 0.25% NDA

Kala Pharmaceuticals Inc. received a complete response letter from the U.S. Food and Drug Administration regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

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FDA approves Nobio’s anti-bacterial dental fillings

Israel’s Nobio Ltd. received approval from the U.S. Food and Drug Administration to market an anti-bacterial composite designed to remain in the teeth for decades.

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U.S. FDA approves Daiichi Sankyo’s treatment for rare joint tumor

The U.S. Food and Drug Administration approved Daiichi Sankyo Co. Ltd.’s Turalio for adult patients with a type of rare, non-cancerous tumor affecting joints and limbs.

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Orion, Bayer prostate cancer drug gets FDA approval

Finland’s Orion and Germany’s Bayer said on Wednesday the U.S. Food and Drug Administration had approved the prostate cancer drug Nubeqa (daroluramide), which the two companies have been developing together.

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Merck’s Keytruda Approved for Esophageal Cancer

The U.S. Food and Drug Administration approved the anti-PD-1 therapy Keytruda as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy.

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FDA Approves First Needle-Free Glucagon to Treat Severe Hypoglycemia

The FDA approved Eli Lilly’s Baqsimi (glucagon) nasal powder 3 mg to treat severe hypoglycemia in diabetics 4 years of age and older.

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