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Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Legacy MEDSearch

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .

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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). FOOD AND DRUG ADMINISTRATION FOR STELLAR KNEE Press Release by: POLARISAR Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. See Full Press Release at the Source: POLARIS AR RECEIVES CLEARANCE FROM THE U.S.

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FDA grants priority review to omalizumab for food allergies

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The study involves patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods.

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Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023 

Pharmaceutical Technology

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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Eli Lilly's Mounjaro shortage worsens ahead of potential obesity FDA approval

Fierce Pharma

Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. As with Novo Nordisk’s popular offering for obesity, Wegovy, demand for Eli Lilly’s dual GIP/GLP-1 agonist Mounjaro appears to be outpacing supply once again. |

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GSK yanks 2 batches of its asthma blockbuster Nucala in Taiwan over glass particle fears

Fierce Pharma

In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. In tandem with Taiwan’s Food and Drug Administration, GSK this week initiated a recall of two batches of its severe asthma injection Nucala after glass fragments were found in a vial of the drug. . |

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FDA Commissioner: Insurers Need To Support Studies In Accelerated Drug Approval Pathway

MedCity News

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration.

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