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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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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.

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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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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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FDA approves Boehringer’s SPEVIGO for psoriasis treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim's SPEVIGO injection to treat generalised pustular psoriasis (GPP).

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FDA accepts Orexo’s NDA for opioid overdose medication

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

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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.