The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Friday, February 12, 2021
Xeris announced the EC has approved Ogluo injection severe hypoglycemia in adults, adolescents, and children aged 2 years and over with diabetes ...
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Friday, February 19, 2021
Pfizer and BioNTech announced an agreement with the EC to supply an additional 200 million doses of COMIRNATY to the 27 EU member states.
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Tuesday, February 23, 2021
Perception Neuroscience announced positive data from its first Phase 1 clinical study demonstrating the safety and tolerability of PCN-101 (R-ketamine...
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Thursday, February 25, 2021
The FDA is advising compounders and health care providers the agency has concerns about the use of certain drugs prepared by compounders to treat ...
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B. Braun Medical have received approval from the FDA for the first and only Acetaminophen Injection available in multiple doses.
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Regeneron and Sanofi announced the FDA has accepted for review the sBLA for Dupixent as an add-on treatment for children with asthma.
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Wednesday, March 10, 2021
Viatris and Kindeva Drug Delivery announced the FDA granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic...
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The FDA posted the seventh spreadsheet of reportable adverse events that Bayer is required to submit as outlined in the April 24, 2020 variance from ...
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Zydus is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, after receiving several complaints of ...
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Amphastar announced the FDA approved the Company’s ANDA for Dextrose injection 50% in the 50 mL Luer-Jet Prefilled Syringe System.
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BioNTech announced the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg.
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Pfizer Inc. and BioNTech announced that BioNTech Europe has entered an agreement with Turkey’s Ministry of Health to supply 60 million additional ...
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AstraZeneca’s COVID-19 vaccine, Vaxzevria, has been granted special approval for emergency use in Japan for active immunization of individuals aged 18...
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On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected ...
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Pfizer Inc. and BioNTech announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies’ COVID-...
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