Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Monday, September 30, 2019
The FDA is announcing an award granting a new five-year contract for the Sentinel System, the FDA’s flagship active surveillance system.
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The FDA has updated two guidances for the temporary compounding of certain human drugs during the COVID-19 public health emergency.
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Wednesday, November 04, 2020
The FDA is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2.
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Wednesday, September 25, 2019
The FDA has announced a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz used to decrease the amount of acid created by the stomach.
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IVD devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick.
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The FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic.
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The FDA has announced the retirement of the MedWatch to Manufacturer Program.
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Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination.
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Wednesday, January 13, 2016
Last year was an exceptionally strong year for biopharmaceutical innovation as the U.S. Food and Drug Administration (FDA) approved 45 new medicines – the highest number of approvals in almost two decades - giving patients even greater hope for the ...
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Thursday, November 21, 2019
The FDA approved Abrilada (adalimumab-afzb), the 5th biosimilar to U.S.-licensed Humira (adalimumab).
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Sterling Pharma Solutions, has announced that its customer, ADC Therapeutics SA, has received FDA approval for the antibody drug conjugate ZYNLONTATM that its Deeside facility contributed to developing.
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Thursday, December 17, 2015
Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) granted approval for Basaglar® (insulin glargine injection) 100 units/mL.
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Wednesday, April 13, 2022
Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Biofrontera Pharma’s cGMP laboratory in Leverkusen, Germany, as a contract laboratory for batch control and stability testing of Ameluz® (aminolevulinic acid ...
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Wednesday, February 18, 2026
Rezon Bio announced that its Warsaw-Duchnice facility has received approval from the FDA for the commercial manufacturing of a biosimilar.
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Wednesday, November 11, 2015
The U.S. Food and Drug Administration has approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of ...
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