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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.
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 ...
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.
FDA Authorizes Stem Cell Trials for Parkinson’s americanpharmaceuticalreview
June 23, 2021
Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a Phase II clinical trial to assess the efficacy and safety of multiple intravenous infusions of allogeneic adipose-derived mesenchymal stem cells in improving ...
Mankind Pharma launches Justoza, a Dapagliflozin approved by USFDA expresspharma
June 23, 2021
The Active Pharmaceutical Ingredient (API) is procured from the Drug Master File (DMF) facility approved by USFDA, EU GMP and WHO GMP, which ensures the highest global efficacy and safety standards.
FDA OKs First Oral Blood Thinning Medication for Children drugs
June 23, 2021
The first oral blood thinning medication for children was approved by the U.S. Food and Drug Administration, the agency announced Monday.
Memos reveal internal FDA struggle over thorny Alzheimer's drug approval firstwordpharma
June 23, 2021
The FDA on Tuesday made public new documents laying bare a struggle within the agency ahead of its controversial decision on June 7 to grant accelerated approval to Biogen and Eisai's Alzheimer's drug Aduhelm (aducanumab) amid heated debate
FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children drugs
June 22, 2021
Today, the U.S. Food and Drug Administration 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
FDA Approves First Oral Blood Thinning Medication for Children fda.gov
June 22, 2021
Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism directly after they have been treated with a blood thinner
Alkem’s St Louis facility gets two observations from US FDA expresspharma
June 21, 2021
Alkem Laboratories informed that the US FDA has issued Form 483 with two observations for its manufacturing facility located in St Louis, US. The US FDA had conducted an inspection of the company’s manufacturing facility from 14-18, June 2021.

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