Tag: Food and Drug Administration

Drugmaker Asks US Regulators for Approval of Over-the-Counter Birth Control Pill

July 11, 2022
Birth ControlBrightBusiness & MarketsCompaniesExecutive BranchFood and Drug AdministrationhealthHealth NewsPoliticsUS
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A drugmaker has asked U.S. regulators for approval for an over-the-counter birth control pill. The pill would be the first one available in the United States over-the-counter (OTC) if the Food and Drug Administration (FDA) approves the application from HRA Pharma. The progestin-only daily pill could be obtained without a prescription if approval goes through….

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Drugmaker Asks US Regulators to Approve Over-the-Counter Birth Control Pill

July 11, 2022
Birth ControlBrightBusiness & MarketsCompaniesExecutive BranchFood and Drug AdministrationhealthHealth NewsPoliticsUS
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A drugmaker has asked U.S. regulators for approval to sell a birth control pill without a prescription. HRA Pharma’s progestin-only daily pill would be the first one available over-the-counter (OTC) in the United States if the Food and Drug Administration (FDA) approves the application. “This historic application marks a groundbreaking moment in contraceptive access and reproductive equity…

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Newly Approved Diabetes Drug Delivers Record-Breaking Weight Loss in Clinical Trial

June 8, 2022
BrightdiabetesFood and Drug AdministrationhealthHealth NewsNews & DiscoveriesUSUS Newsweight loss
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A type 2 diabetes (T2D) drug recently approved by the Food and Drugs Administration (FDA) has reportedly reduced more than 20 percent of weight in obese individuals by administering the drug once every week. The SURMOUNT-1 study, a Phase 3 trial led by Yale University researchers testing the efficacy and safety of tirzepatide, found that…

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US Regulators Reject Request to Clear Cheap Drug for Treatment of COVID-19

May 19, 2022
BrightCCP VirusCovid NewsEditor's PicksfluvoxamineFood and Drug AdministrationhealthHealth NewsPUBLIC HEALTH INFORMATION
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U.S. regulators have rejected a request to grant emergency authorization to a cheap drug for the treatment of COVID-19, drawing criticism from one of the doctors that asked for the clearance. The Food and Drug Administration (FDA), in a 27-page memorandum explaining its decision, said that the benefit of fluvoxamine was “not persuasive when focusing…

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Pfizer Hired 600 Employees Due to ‘Large Increase of Adverse Event Reports’: Document

April 8, 2022
AMERICABusiness & EconomyBusinesses in COVID-19CCP VirusEditor's PicksFood and Drug AdministrationPfizerUSUS NewsVaccines & Safety
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Pfizer hired 600 employees in the months after its COVID-19 vaccine was authorized in the United States due to the “large increase” of reports of side effects linked to the vaccine, according to a document prepared by the company. Pfizer has “taken a multiple actions to help alleviate the large increase of adverse event reports,”…

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Experts Divided on US Drug Regulators Revoking Authorization of Key COVID-19 Treatments

January 27, 2022
AMERICABrightCCP VirusFood and Drug AdministrationHealth NewsMind & Bodymonoclonal antibodiesPUBLIC HEALTH INFORMATION
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The Food and Drug Administration’s decision to effectively revoke emergency use authorization for two monoclonal antibody treatments has left experts divided, with some calling it the right move and others asserting it shouldn’t have been done. The agency, of the FDA, on Jan. 24 announced it was barring use of treatments from Eli Lilly and…

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FDA Says No Safety Signals From Booster Shots After European Regulator Warning

January 15, 2022
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The Food and Drug Administration (FDA) says its experts have not seen indications of safety problems from COVID-19 vaccine booster shots after European and international officials expressed concern about how repeat boosters may impact immune systems. “FDA is aware of the EMA report. To date, we have not seen any safety signals regarding booster shots…

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US Regulator Adds Bleeding Risk to J&J COVID-19 Vaccine Fact Sheets

January 12, 2022
BrightCCP VirusEditor's PicksFood and Drug AdministrationHealth NewsJohnson JohnsonMind & BodyVaccines & Safety
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Food and Drug Administration officials on Tuesday added a bleeding risk to fact sheets for Johnson & Johnson’s COVID-19 vaccine. Healthcare providers administering the vaccine and recipients and caregivers are now being told that there’s a safety signal for immune thrombocytopenia, a disorder stemming from low platelet levels that can cause excessive bleeding. “Reports of adverse…

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NIH Director Says Omicron Unlikely the Last Variant of COVID-19

December 6, 2021
CCP VirusCenters for Disease Control and PreventionExpert ViewFood and Drug AdministrationHealth NewsMind & BodyNational Institutes of HealthOmicronUSUS NewsWorld
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The director of the National Institutes of Health (NIH) says that Omicron is likely not the last variant that will emerge from the original coronavirus. “It’s certainly possible that this is not the last emerging variant that will attract a lot of attention and a lot of concern,” Dr. Francis Collins said in an interview…

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FDA Approves Merck’s Keytruda Combo for Early Breast Cancer Treatment

July 28, 2021
Breast cancerBusinesschemotherapyCompaniesFood and Drug AdministrationInternationalMerck & CoUSUS NewsWorld
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Merck & Co Inc. said on Tuesday that the U.S. Food and Drug Administration approved its immunotherapy Keytruda as a treatment for an early form of tough-to-treat breast cancer in combination with chemotherapy. The FDA approval is for treating triple-negative breast cancer (TNBC), an aggressive form of the disease with an increased risk of recurrence….

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