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Vernalis: FDA Issues CRL on CCP-07 NDA

Vernalis plc announces today that the US Food and Drug Administration issued a Complete Response Letter (CRL) regarding the New Drug Application for CCP-07.

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Roche’s Tecentriq wins FDA approval for treating advanced bladder cancer

Genentech – a unit of Swiss drugmaker Roche Holding – got approval from the U.S. FDA for its already-approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer.

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FDA declines to approve arthritis drug Olumiant

The U.S. Food and Drug Administration declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co. and partner Incyte Corp.

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FDA warns Abbott Labs over heart devices

The U.S. FDA issued a warning letter to Abbott citing manufacturing flaws with cardiovascular devices acquired with its purchase of St. Jude Medical.

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FDA approves movement disorder drug

The U.S. FDA approved Neurocrine Biosciences Inc.’s drug to treat tardive dyskinesia, an uncontrolled movement side effect of antipsychotic medications.

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FDA Picks Emulate for Organ Chip Technology

The U.S. FDA’s Office of Foods and Veterinary Medicine entered into a cooperative R&D agreement to “evaluate and qualify” Emulate Inc.’s organ-on-a-chip technology.

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FDA Approves New Indications for Harvoni. Sovaldi

The U.S. FDA approved supplemental indications for Gilead Sciences’ Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets.

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FDA rejects application for diabetes drug labels

The FDA declined an application to include labeling info for Merck’s Januvia and Janumet that the diabetes drugs do not raise the risk of major heart problems.

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EMA clears Actelion’s Uptravi after safety review

The European Medicines Agency gave its green light for doctors to continue using Actelion’s Uptravi, saying a review after five patient deaths in France did not suggest an increase in mortality linked to the PAH drug.

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FDA allows marketing of DTC tests for diseases

The U.S. FDA has allowed marketing of 23andMe Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions.

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Corbus outlines U.S. approval path for lead drug

The FDA needs Corbus Pharmaceuticals to show positive data from one late-stage study on its experimental scleroderma treatment to support a marketing application.

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Teva Wins FDA Approval for Austedo

Teva finally won approval from the U.S. FDA for Austedo, a treatment for chorea associated with Huntington’s disease.

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Tagrisso Receives US FDA Full Approval

The U.S. FDA granted full approval for Tagrisso (osimertinib) 80-mg once-daily tablets for treating metastatic EGFR T790M mutation-positive NSCLC.

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Novartis Wins Speedy Review of Leukemia Drug

In the race to get a CAR-T therapeutic to the market, Novartis announced that the U.S. FDA accepted its BLA filing and granted priority review for CTL019.

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U.S. approves Roche drug for severe form of MS

Roche’s multiple sclerosis drug Ocrevus won U.S. approval, putting the potential blockbuster back on track after a brief delay.

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FDA approves eczema drug Dupixent

The FDA approved Regeneron and Sanofi’s Dupixent for atopic dermatitis, a product widely seen as the most important future growth driver for the companies.

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FDA approves Tesaro’s ovarian cancer drug

The U.S. Food and Drug Administration approved Tesaro Inc.’s drug, Zejula (niraparib), for the treatment of recurrent ovarian cancer.

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Chinese drug approval for AstraZeneca’s Tagrisso

AstraZeneca has won approval for its lung cancer pill Tagrisso in China, a key market for the potential blockbuster medicine.

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FDA Approves Symproic for OIC

The U.S. FDA approved Symproic (naldemedine) 0.2 mg tablets C-II for treating opioid-induced constipation in adult patients with chronic non-cancer pain.

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FDA Grants Approval for Bavencio

The U.S. FDA approved Bavencio (avelumab) Injection 20 mg/mL for ttreating adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.

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