• Cara Therapeutics and Vifor Pharma announce USFDA approval of KORSUVA injection for the treatment of moderate-to-severe pruritus in hemodialysis patients
    24 August 2021

    Cara Therapeutics and Vifor Pharma announce USFDA approval of KORSUVA injection for the treatment of moderate-to-severe pruritus in hemodialysis patients

    Cara Therapeutics and Vifor Pharma announced that the U.S. Food and Drug Administration has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis . KORSUVA injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system.

  • FDA accepts Agios priority review of NDA for Mitapivat
    18 August 2021
    FDA accepts Agios priority review of NDA for Mitapivat

    CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE)  Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency.

  • FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors
    18 August 2021
    FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors

    SAN DIEGO, Aug. 17, 2021 (GLOBE NEWSWIRE) -- AnaptysBio, Inc , a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that the U.S.

  • Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals
    17 August 2021
    Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals

    Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

  • FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment
    17 August 2021
    FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment

    The U.S. Food and Drug Administration approved a new indication for Xywav for idiopathic hypersomnia in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

  • US FDA grants Priority Review to Roches Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
    3 August 2021
    US FDA grants Priority Review to Roches Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

    Basel, 3 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-approved test.

  • FDA accepts application for Roche faricimab for the treatment of neovascular age related macular degeneration and diabetic macular edema
    29 July 2021
    FDA accepts application for Roche faricimab for the treatment of neovascular age related macular degeneration and diabetic macular edema

    Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.

  • Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Hypothalamic Obesity
    26 July 2021
    Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Hypothalamic Obesity

    Saniona a clinical stage biopharmaceutical company focused on rare diseases announced that the U.S. Food and Drug Administration has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity. Tesomet is the first and only investigational treatment for HO to receive orphan drug designation. Saniona is preparing to initiate two Phase 2b studies of Tesomet in the second half of this year, one in HO and the other in Prader-Willi syndrome, for which Tesomet has already received orphan drug status.

  • Zydus Cadila receives tentative approval from the USFDA for Ibrutinib Tablets
    26 July 2021
    Zydus Cadila receives tentative approval from the USFDA for Ibrutinib Tablets

    Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

  • FDA granted Breakthrough Therapy designation to pneumoniae vaccine
    16 July 2021
    FDA granted Breakthrough Therapy designation to pneumoniae vaccine

    Affinivax, Inc and Astellas Pharma Inc announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. Developed using Affinivaxs proprietary MAPS (Multiple Antigen-Presenting System) platform technology, ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated.

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