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FDA approval

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/

FDA approves the first smallpox treatment

FDA approves the first smallpox treatment

Siga Technologies has won US approval for Tpoxx, the first drug to be licensed to treat smallpox which, despite

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FDA approves the first smallpox treatment

https://pharmaphorum.com/news/fda-smallpox-tpoxx-siga-technologies/

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