Entries by Business Wire

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Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.

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Pear Therapeutics Announces Program to Bring Prescription Digital Therapeutics to Patients in Recovery Through a Telehealth Provider Experience

Pear Therapeutics, Inc. has announced a program to offer patients seeking treatment for substance use disorder (SUD) or opioid use disorder (OUD) access to a telehealth provider through its “find a provider tool”, along with in-person care options.

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Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory LBCL

The U.S. Food and Drug Administration approved Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

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U.S. FDA Approves Cabenuva for Virologically Suppressed Adolescents Living With HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg

The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

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Bayer to Highlight New Cardiovascular and Renal Data at ACC.22, Including Late-Breaking Presentations for KERENDIA as Well as Oral Factor XIa Inhibitor Program

Bayer will present a range of new clinical data at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22), being held April 2-4, 2022, in Washington, D.C. Data from KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA)1 and asundexian, an investigational oral Factor XIa inhibitor2 will be presented at the meeting. These data highlight Bayer’s ongoing commitment to patients with cardiovascular (CV) and kidney diseases.