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Lilly to Seek FDA Approval for New Drug for Alzheimer Disease
drugs
June 28, 2021
Fresh on the heels of the U.S. Food and Drug Administration approval of the controversial Alzheimer disease drug Aduhelm, the maker of a second medicine that works in similar fashion said Thursday it hopes to apply for approval of its medication later .
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Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19
fda.gov
June 28, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older)
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FDA issues Emergency Use Authorization for Oral CovAb™ SARS-CoV-2 Ab Test
americanpharmaceuticalreview
June 25, 2021
Diabetomics, Inc., announced the granting of an Emergency Use Authorization (EUA) by the US FDA for the Company's CovAb™ SARS-CoV-2 Ab point-of-care test. The product had also received a CE mark for marketing in the EU earlier.
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FDA grants breakthrough status to Eisai and Biogen’s Alzheimer’s drug
pharmaceutical-technology
June 25, 2021
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eisai and Biogen’s lecanemab (BAN2401) for Alzheimer’s disease (AD) treatment.
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Zydus Cadila receives tentative approval from USFDA for Pemetrexed for Injection
expresspharma
June 25, 2021
Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.
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Cipla gets USFDA nod for inhalation product
expresspharma
June 25, 2021
The approved product is a generic version of Sunovion Pharmaceuticals Inc's Brovana.
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Zydus Cadila receives tentative approval from USFDA for Fingolimod Capsules .25mg
expresspharma
June 25, 2021
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
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FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines
firstwordpharma
June 24, 2021
The FDA will add a warning about rare cases of heart inflammation in adolescents and young adults to fact sheets for the Pfizer/BioNTech and Moderna COVID-19 vaccines, as reported by the National Post.
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FDA Approves First Oral Blood Thinner for Children
americanpharmaceuticalreview
June 23, 2021
The U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood ...
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FDA Approves Over-the-Counter Nasal Antihistamine
americanpharmaceuticalreview
June 23, 2021
The U.S. FDA approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch.