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FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients
Monday, February 24, 2025 - 10:20am | 383On Monday, the FDA declined Invivyd, Inc.’s (NASDAQ:IVVD) request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for Pemgarda (pemivibart) for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe...
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DeSantis Administration Cautions Against Pfizer, Moderna mRNA Covid Vaccines for Vulnerable Individuals, Cites Concerns Related To Rare Heart Conditions
Monday, September 16, 2024 - 11:18am | 596Florida Governor Ron DeSantis' administration has reportedly issued updated guidance recommending that healthcare providers steer vulnerable patients away from mRNA-based COVID-19 vaccines. The Florida Health Department is raising concerns about the safety of the mRNA vaccines, pointing to...
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Americans To Access COVID-19 Test Kits For Free As US Government Restarts Free At-Home Program
Monday, August 26, 2024 - 11:24am | 591Starting in late September, U.S. households can order up to four COVID-19 nasal swab tests when the federal program reopens. The exact date for ordering has not been announced, according to the official website, COVIDtests.gov. The U.S. Department of Health and Human Services (HHS), which oversees...
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Struggling COVID-19 Vaccines From AstraZeneca, BioNTech/Pfizer, Moderna Cut Incidence Of Arterial Thromboses That Cause Heart Attacks, Strokes, British Study Shows
Tuesday, August 13, 2024 - 2:43pm | 592Researchers from the Universities of Cambridge, Bristol, and Edinburgh have revealed that COVID-19 vaccinations may significantly reduce the incidence of arterial thromboses, a leading cause of heart attacks and strokes. The study, published in Nature Communications and supported by the British...
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Long Covid Remains Diagnostic Mystery, Diagnosis Remains Elusive; National Institutes of Health-Funded Study Shows
Tuesday, August 13, 2024 - 1:33pm | 469Long Covid continues to evade clear diagnostic testing, as researchers from the National Institute of Health’s RECOVER Initiative revealed in a study published in the Annals of Internal Medicine. Despite examining data from over 10,000 patients across 83 clinical sites, the study found no...
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Humanigen Downfall: FDA Rejection For COVID-19 Drug Triggers Financial Crisis, Bankruptcy
Friday, January 5, 2024 - 11:55am | 367Humanigen (OTC:HGEN) has filed for bankruptcy likely as a result of the U.S. Food and Drug Administration’s (FDA) rejection of its COVID-19 drug, lenzilumab. The company, previously linked with disgraced pharmaceutical entrepreneur Martin Shkreli, reported unsecured debts of $44.1 million...
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COVAX Global Initiative For COVID-19 Vaccines Comes To An End Amid Shift To Regular Programs
Wednesday, December 20, 2023 - 11:54am | 305COVAX, the multilateral mechanism for equitable global access to COVID-19 vaccines launched in 2020, will close on 31 December 2023. Jointly led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, UNICEF, and the World Health Organization (WHO...
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Timing Favors Novavax's Delayed Approval, Arrival Ahead of Peak COVID Vaccine Demand
Monday, October 9, 2023 - 2:23pm | 406Last week, Novavax Inc (NASDAQ: NVAX) received FDA authorization for its updated COVID-19 vaccine, targeting the omicron subvariant XBB.1.5 in individuals aged 12 and older. Wall Street analysts are optimistic about Novavax's prospects despite its vaccine's release...
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Privatized Vaccine Distribution Sparks Confusion, Payment Challenges
Monday, October 9, 2023 - 12:40pm | 693As the rollout of the updated COVID-19 vaccine progresses, some individuals have been surprised by requests for upfront payments ranging from $150 to $200. The U.S. government has shifted responsibility for vaccine distribution, administration, and payment coverage to private companies,...
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Small Biotech Promosome Drops Lawsuit Against Pfizer, BioNTech in COVID-19 Vaccine Patent Dispute
Thursday, October 5, 2023 - 3:04pm | 420Biotech firm Promosome has agreed to end the lawsuit, which accused the COVID-19 vaccine manufacturers, Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX), of patent infringement related to messenger RNA technology. However, the financial terms of the...
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US Government Ceases Free Distribution Of Merck's COVID-19 Pill
Thursday, October 5, 2023 - 8:59am | 430The U.S. government is set to cease the distribution of free doses of Merck & Co Inc's (NYSE: MRK) COVID-19 antiviral treatment Lagevrio (molnupiravir), by mid-November, shifting its availability to the commercial market. The Administration for Strategic Preparedness and...
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Uncertainty Looms Over Pfizer's Oral COVID-19 Antiviral Pill - Doubts Over Commercial Approval
Wednesday, September 27, 2023 - 8:54am | 354Pfizer Inc's (NYSE: PFE) CEO Albert Bourla provided an update on the status of the company's oral antiviral COVID-19 treatment, Paxlovid, during his speech at the Cantor Fitzgerald Annual Healthcare Conference. Bourla revealed that approximately 250,000 courses of Paxlovid are...
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Moderna Talks Offer Hope for Enhanced COVID-19 Vaccine Availability In Europe
Tuesday, September 26, 2023 - 12:31pm | 340European countries are actively negotiating a fresh COVID-19 vaccine procurement agreement with Moderna Inc (NASDAQ: MRNA) as concerns mount within EU health authorities regarding a surge in coronavirus infections. Member states can express their interest in the deal individually,...
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Biden Administration Restarts Distribution Of Free At Home COVID-19 Tests, After Suspending For Year
Thursday, September 21, 2023 - 7:16am | 290In response to the escalating spread of the virus nationwide, the Biden administration declared that it would recommence offering free at-home COVID tests to American households starting next Monday. Last September, the federal government suspended its offer of free at-home COVID-19 tests....
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Updated Covid Vaccine US Rollout Hit by Insurance Coverage Delays - What It Means?
Wednesday, September 20, 2023 - 2:15pm | 385As the U.S. launches a fresh round of updated COVID-19 vaccines, some patients encounter hurdles in obtaining prompt health insurance coverage for their shots. Under the recommendation of U.S. regulators, Pfizer Inc (NYSE: PFE)/ BioNTech SE (NASDAQ: BNTX) and Moderna...