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FDA approval

FDA approves biosimilar of blockbuster Humira

FDA approves biosimilar of blockbuster Humira

A Humira biosimilar, produced by drug maker Sandoz, has been given the green light from the US Food

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FDA approves biosimilar of blockbuster Humira

https://pharmaphorum.com/news/fda-approves-biosimilar-blockbuster-humira/

Opdivo and Keytruda approved in new lung cancer uses

Opdivo and Keytruda approved in new lung cancer uses

The FDA has approved Merck’s Keytruda (pembrolizumab) as a combination treatment for metastatic nonsquamous non-small cell lung cancer

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Opdivo and Keytruda approved in new lung cancer uses

https://pharmaphorum.com/news/bmss-opdivo-approved-lung-cancer/

Amicus’ oral Fabry disease drug approved in US

Amicus’ oral Fabry disease drug approved in US

Decision follows approval in Europe

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Amicus’ oral Fabry disease drug approved in US

https://pharmaphorum.com/news/amicus-oral-fabry-disease-drug-approved/

Contraception app Natural Cycles approved by the FDA

Contraception app Natural Cycles approved by the FDA

The US regulator has cleared Natural Cycles, the first direct-to-consumer smart phone application as a form of “digital

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Contraception app Natural Cycles approved by the FDA

https://pharmaphorum.com/news/contraception-app-natural-cycles-approved/

FDA approves generic under new strategy to boost competition

FDA approves generic under new strategy to boost competition

The US regulator has approved a drug to treat low potassium as the first generic with the Competitive

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FDA approves generic under new strategy to boost competition

https://pharmaphorum.com/news/fda-approved-hypokalymia-generic-cgt/

Pain Therapeutics’ opioid drug fails to gain FDA approval

Pain Therapeutics’ opioid drug fails to gain FDA approval

The US regulator has rejected Pain Therapeutics’ abuse-deterrent opioid painkiller drug, Remoxy, for the fourth time. In a

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Pain Therapeutics’ opioid drug fails to gain FDA approval

https://pharmaphorum.com/news/opioid-drug-fails-gain-fda-approval/

Shionogi’s Mulpleta gets FDA green light for patients with liver disease

Shionogi’s Mulpleta gets FDA green light for patients with liver disease

The US drug regulator has approved Mulpleta (lusutrombopag) as a treatment for thrombocytopenia in certain patients with chronic

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Shionogi’s Mulpleta gets FDA green light for patients with liver disease

https://pharmaphorum.com/news/shionogis-mulpleta-gets-fda-green-light-for-patients-with-liver-disease/

Indivior’s once-monthly schizophrenia injection gets US green light

Indivior’s once-monthly schizophrenia injection gets US green light

Regulators authorities in the US have approved Indivior’s long-acting injectable treatment for adults with schizophrenia. Perseris (risperidone) won

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Indivior’s once-monthly schizophrenia injection gets US green light

https://pharmaphorum.com/news/indivior-schizophrenia-perseris-fda/

Prostate drug approved for use in non-metastatic cases

Prostate drug approved for use in non-metastatic cases

The US Food and Drug Administration has approved the drug Xtandi (enzalutamide) to treat men with advanced non-metastatic

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Prostate drug approved for use in non-metastatic cases

https://pharmaphorum.com/news/prostate-drug-approved-for-use-in-non-metastatic-cases/

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