FDA | PRIME Journal

Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation

Feb 1, 2021 | News | 0 |

Galderma announces that the U.S. Food and Drug Administration (FDA) has...

FDA approves Libtayo® (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma

Oct 8, 2018 | News | 0 |

The U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell...

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Oct 5, 2018 | News | 0 |

When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of...

AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.

Sep 21, 2018 | News | 0 |

AVITA Medical, a global regenerative medicine company, announced that the U.S. Food and Drug Administration (FDA) approved the Company’s Premarket Approval...

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

Sep 7, 2018 | News | 2 |

Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to...

FDA approves new treatment for a rare genetic disorder, Fabry disease

Aug 13, 2018 | News | 0 |

The U.S. Food and Drug Administration approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease....

Cynosure Receives FDA 510(k) Clearance for SculpSure™, the World’s First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction

May 20, 2015 | News, Sponsored | 0 |

Cynosure, Inc. a leader in laser- and light-based aesthetic treatments, today announced that it has received 510(k) clearance from the...

Galderma receives FDA approval of novel treatment option for rosacea patients

Dec 24, 2014 | News | 0 |

Soolantra® (ivermectin) Cream, 1% found to be well tolerated with powerful results seen as early as two weeks

Tag: FDA

Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation

FDA approves Libtayo® (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

FDA approves new treatment for a rare genetic disorder, Fabry disease

Cynosure Receives FDA 510(k) Clearance for SculpSure™, the World’s First Hyperthermic Laser Treatment for Non-Invasive Fat Reduction

Galderma receives FDA approval of novel treatment option for rosacea patients

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