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FDA Agrees to Use of New Manufacturing Process for Nomacopan in Clinical Studies contractpharma
January 19, 2022
New manufacturing process increases the final yield of nomacopan at least five-fold, compared to the previous process.
Vivera Pharmaceuticals Issues Statement Regarding LuSys Laboratories COVID-19 Tests prnewswire
January 17, 2022
Vivera Pharmaceuticals is highly discouraged to read the latest FDA safety communication that erroneously lists Vivera Pharmaceuticals as a brand of LuSys Laboratories or as a distributor of the LuSys Eagle Diagnostics test.
US FDA amends J&J vaccine fact sheet to include rare bleeding risk ExpressPharma
January 14, 2022
The amendment fact sheet follows similar moves for the vaccine by other regulators, including that of the European Medicines Agency (EMA) in October.
Agile Therapeutics Acknowledges New Government Guidance Reinforcing Requirement to Cover Contraceptives that a Woman and Her Heathcare Provider Determine are Medically Appropriate at No Cost FirstWordPharma
January 13, 2022
On January 10, 2022, the tri-agencies, Department of Labor (DOL), Health and Human Services (HHS) and Treasury issued new guidance that supports women's access to U.S. Food and Drug Administration (FDA) approved contraceptive products.
FDA Approves Monoclonal Antibody to Treat Arthritis in Cats drugs.com
January 13, 2022
Arthritis can keep a cat from doing many of the things that kitties love to do. But now there's hope: The first treatment to ease arthritis pain in cats has been approved by the U.S. Food and Drug Administration.
Alembic Pharmaceuticals receives US FDA tentative approval for Dronedarone tablets ExpressPharma
January 11, 2022
Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation
FDA reduces time for Moderna Covid-19 vaccine booster to five months Pharmaceutical-Technology
January 11, 2022
Common booster shot side effects include injection area pain, redness and swelling and fatigue.
Do Not Use At-Home COVID Test Swabs in the Throat: FDA drugs
January 10, 2022
Swabs that come with at-home rapid antigen COVID-19 tests should be used in the nose and not the throat, the U.S. Food and Drug Administration warns.
FDA Warns Against Using At-Home COVID-19 Test Swabs in the Throat drugs
January 10, 2022
Swabs that come with at-home rapid antigen COVID-19 tests should be used in the nose and not the throat, the U.S. Food and Drug Administration warns.
How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product FDA
January 07, 2022
CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products.

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