NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) Pomerantz LLP announces that a class action lawsuit has been filed against Kadmon Holdings, Inc. ("Kadmon" or the .
Pfizer, Inc. (NYSE: PFE) and
Myovant Sciences (NYSE: MYOV) announced FDA approval for once-daily Myfembree, relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg, for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.
The companies said they will jointly commercialize Myfembree in the U.S. Myfembree is expected to be available in June.
Pfizer shares edged down 0.15% to $38.86 in after-hours trading and Myovant receded 0.34% to $23.60.
Zosano Announces Publication Of Positive Results From Long-Term Use Of Migraine Drug
Zosano Pharma Corporation (NASDAQ: ZSAN) announced that an article titled, Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine was published in the Journal of Headache and Pain
U S Food and Drug Administration Grants BCMA CAR-T Cilta-cel Priority Review for the Treatment for Relapsed/Refractory Multiple Myeloma streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Provention Bio Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Teplizumab
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RED BANK, N.J., May 25, 2021 /PRNewswire/ Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced today that the U.S. Food and Drug Administration (FDA) posted briefing documents for the May 27, 2021 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the Biologics License Application (BLA) for teplizumab, Provention Bio s investigational drug candidate for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
The Advisory Committee meeting is scheduled for 9:00 a.m. EST on Thursday, May 27. The briefing materials and the meeting can be accessed at: https://investors.proventionbio.com/events. The Company is not responsible for the content of, nor the statements made in, the briefing materia
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Pfizer Initiates Study Exploring Coadministration of Its 20-valent Pneumococcal Conjugate Vaccine Candidate Along With a Third Dose of Pfizer-BioNTech COVID-19 Vaccine
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.