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.
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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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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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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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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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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B. Braun Medical have received approval from the FDA for the first and only Acetaminophen Injection available in multiple doses.
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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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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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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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Friday, February 12, 2021
Pfizer and BioNTech announced the U.S. government has exercised its option for an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine...
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Friday, February 12, 2021
The FDA has informed Mallinckrodt it is deferring action on the Stratatech BLA for StrataGraft.
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Friday, February 12, 2021
Moderna announced the Canadian Government has increased its confirmed order commitment by 4 million doses of the COVID-19 Vaccine Moderna.
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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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Wednesday, February 10, 2021
PaxMedica announced positive topline data from its trial PAX-101 as a potential treatment for the core symptoms of Autism.
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Thursday, February 04, 2021
Valneva has commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies.
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