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All News - Page 48

FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
January 6, 2022
Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
January 5, 2022
But Paxlovid and molnupiravir will be available only at certain Walmart and Sam’s Club locations.
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
January 3, 2022
A review of real-world data from Israel didn't show any increase risk of myocardities or pericarditis.
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's in 2022
January 2, 2022
ICER's analysis is slated to include two as-yet unapproved monoclonal antibody treatments, donanemab and lecanemab, as well as Aduhelm (aducanumab).
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
December 31, 2021
The FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-akko) for severe asthma. But the drug may have limited uptake in the near term, according to one analyst.
Best Read Articles on Safety Issues and Recalls in 2021
Best Read Articles on Safety Issues and Recalls in 2021
Best Read Articles on Safety Issues and Recalls in 2021
December 30, 2021
News about counterfeit versions of Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) and Descovy (emtricitabine, tenofovir alafemamide) and the pause in the REMS program for clozapine were among the best read articles of 2021.
Best Read Articles on Formularies and Formulary Changes in 2021
Best Read Articles on Formularies and Formulary Changes in 2021
Best Read Articles on Formularies and Formulary Changes in 2021
December 29, 2021
Our best read stories about formularies include news about 2022 formularies from CVS Caremark and Express Scripts.
Best Read Articles on Biosimilars in 2021
Best Read Articles on Biosimilars in 2021
Best Read Articles on Biosimilars in 2021
December 28, 2021
News about interchangeable Semglee (insulin glargine-yfgn) was among the most read in 2021.
Best Read Articles on News Not Related to COVID-19 in 2021
Best Read Articles on News Not Related to COVID-19 in 2021
Best Read Articles on News Not Related to COVID-19 in 2021
December 27, 2021
Apotex's importation of Chantix (varenicline) and Express Scripts' formulary exclusions were among the best read articles this year that didn't concern COVID-19.
Best Read Articles on FDA News in 2021
Best Read Articles on FDA News in 2021
December 26, 2021
The FDA's warning about Xeljanz (tofacitinib) and other JAK inhiitors and the extension of its review of Janssen's CAR T therapy for multiple myeloma were among the best read articles about the agency in 2021.
Best Read Articles on COVID-19 Drug-Related News in 2021
Best Read Articles on COVID-19 Drug-Related News in 2021
Best Read Articles on COVID-19 Drug-Related News in 2021
December 25, 2021
The attention-getting articles about COVID-19 included news about Pfizer's booster and the FDA's rejection Zyesami (aviptadil) for treatment of COVID-19-related respiratory failure.
Best Read Articles on FDA Approvals in 2021
Best Read Articles on FDA Approvals in 2021
Best Read Articles on FDA Approvals in 2021
December 24, 2021
The approval of the generic version of smoking-cessation drug Chantix (varenicline) garnered a lot of attention as did the OKs of Besremi (ropeginterferon alfa-2b-njft), a treatment for polycythemia vera, and Trudhesa (dihydroergotamine mesylate), a nasal spray for acute treatment of migraines.
Quality of Patient-Reported Outcomes in Oncology Trials Improves
Quality of Patient-Reported Outcomes in Oncology Trials Improves
Quality of Patient-Reported Outcomes in Oncology Trials Improves
December 23, 2021
Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.
Areva to Import Bupivacaine from Italy
Areva to Import Bupivacaine from Italy
Areva to Import Bupivacaine from Italy
December 22, 2021
This is the Areva's second importation of bupivacaine this year.
Monoclonal Antibody for Relapsing MS on the Way
Monoclonal Antibody for Relapsing MS on the Way
Monoclonal Antibody for Relapsing MS on the Way
December 21, 2021
The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.
Study: Increasing Medicaid Rebates on Accelerated Approvals Saves Money
Study: Increasing Medicaid Rebates on Accelerated Approvals Saves Money
Study: Increasing Medicaid Rebates on Accelerated Approvals Saves Money
December 20, 2021
During the period 2015 to 2020, if a proposed policy that increases Medicaid rebates for drugs with accelerated approvals had been enacted, up to $5.2 billion could have been saved.
FDA Updates REMS for CAR T-Cell Therapies
FDA Updates REMS for CAR T-Cell Therapies
FDA Updates REMS for CAR T-Cell Therapies
December 17, 2021
Because of a COVID-19 related shortage, facilities may not have immediate access to Actemra, which is required as part of the REMS programs for CAR T-cell therapies.
FDA Significantly Expands Indication for Zynrelef Analgesia
FDA Significantly Expands Indication for Zynrelef Analgesia
FDA Significantly Expands Indication for Zynrelef Analgesia
December 16, 2021
The broader indication for Zynrelef now covers around 7 million procedures annually and reduces the need for post-surgery opioids.
Online Pharmacies that Sell Counterfeit Drugs Grew During the Pandemic
Online Pharmacies that Sell Counterfeit Drugs Grew During the Pandemic
Online Pharmacies that Sell Counterfeit Drugs Grew During the Pandemic
December 15, 2021
Consumers have a false sense of security about buying drugs from online platforms.
New Data Supports COVID-19 Booster for Blood Cancer Patients
New Data Supports COVID-19 Booster for Blood Cancer Patients
New Data Supports COVID-19 Booster for Blood Cancer Patients
December 14, 2021
Blood cancer patients who had at least some antibodies after the first two doses are likely to produce large amounts after the third vaccination.
Medicare Could Save with Use of Generic Cardiovascular Meds
Medicare Could Save with Use of Generic Cardiovascular Meds
Medicare Could Save with Use of Generic Cardiovascular Meds
December 13, 2021
Researchers suggest that adjusting the prescribing patterns of about 8% of physicians could result in substantial savings.
Medexus Initiates Second Importation of Triamcinolone Hexacetonide from France
Medexus Initiates Second Importation of Triamcinolone Hexacetonide from France
Medexus Initiates Second Importation of Triamcinolone Hexacetonide from France
December 11, 2021
Medexus is working with Ethypharm to generate the data needed to support an abbreviated new drug application for triamcinolone hexacetonide.
FDA Committee Votes No on Bardoxolone for CKD
FDA Committee Votes No on Bardoxolone for CKD
FDA Committee Votes No on Bardoxolone for CKD
December 10, 2021
The regulatory agency is reviewing Reata’s application of bardoxolone to treat patients with chronic kidney disease caused by Alport syndrome, a rare genetic disease.
Pfizer/BioNTech COVID-19 Booster EUA Expanded to Ages 16 to 17
Pfizer/BioNTech COVID-19 Booster EUA Expanded to Ages 16 to 17
Pfizer/BioNTech COVID-19 Booster EUA Expanded to Ages 16 to 17
December 9, 2021
The FDA in late November authorized the COVID-19 booster for all people 18 years of age and older.
FDA Grants Emergency Use of AstraZeneca’s COVID-19 Prevention Med
FDA Grants Emergency Use of AstraZeneca’s COVID-19 Prevention Med
FDA Grants Emergency Use of AstraZeneca’s COVID-19 Prevention Med
December 9, 2021
Evusheld is the only monoclonal antibody authorized in the United States for COVID-19 pre-exposure prophylaxis.
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