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Myovant Sciences Announces European Commission Approval for ORGOVYX® (relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer

Posted: May 2, 2022 at 2:43 am

BASEL, Switzerland, April 29, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) today announced that the European Commission (EC) has approved the marketing authorisation application for ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The approval is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

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Myovant Sciences Announces European Commission Approval for ORGOVYX® (relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer

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Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults

Posted: May 2, 2022 at 2:43 am

ROCKVILLE, Md., April 29, 2022 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.

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Tarsus to Host Webcast to Review Topline Results from Saturn-2 Phase 3, the Second Pivotal Trial of TP-03 for the Treatment of Demodex Blepharitis

Posted: May 2, 2022 at 2:43 am

IRVINE, Calif., April 29, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, will hold a webcast on Monday, May 2, 2022 at 5:00am PT/8:00am ET to review the topline results from the Saturn-2 Phase 3 trial for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis and provide a brief corporate update.

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Tarsus to Host Webcast to Review Topline Results from Saturn-2 Phase 3, the Second Pivotal Trial of TP-03 for the Treatment of Demodex Blepharitis

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Saniona publishes its Annual Report for 2021

Posted: May 2, 2022 at 2:43 am

PRESS RELEASE

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Saniona publishes its Annual Report for 2021

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Ascendis Pharma A/S to Present New Endocrinology Results at Four Medical Meetings in May

Posted: May 2, 2022 at 2:43 am

New data highlights include:

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Ascendis Pharma A/S to Present New Endocrinology Results at Four Medical Meetings in May

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Kala Pharmaceuticals to Present Clinical Data for KPI-012, its Mesenchymal Stem Cell Secretome Product, for the Treatment of PCED at the 2022 ARVO…

Posted: May 2, 2022 at 2:43 am

-- Data Demonstrate Rapid and Complete Wound Healing, with Six of Eight (75%) Patients Achieving Complete Healing within Four Weeks; All Remained Healed Through End of Follow-Up ---- All Patients with Pain at Baseline Reported Zero Pain by Week 3 ---- KPI-012 was Well-Tolerated with No Significant Safety Issues Observed ---- On Track to Submit Investigational New Drug Application (IND) and Initiate Phase 2/3 Trial in 4Q 2022 --ARLINGTON, Mass., May 01, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported clinical data from a Phase 1b trial of KPI-012, its novel, cell-free secretome therapy for the treatment of severe ocular diseases driven by impaired healing. As previously disclosed, treatment with KPI-012 was well tolerated and resulted in significant improvements in patients with various persistent corneal epithelial defect (PCED) etiologies, with complete healing of the PCED in six of eight evaluable patients. The data will be presented on Tuesday, May 3 in a poster session at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

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Kala Pharmaceuticals to Present Clinical Data for KPI-012, its Mesenchymal Stem Cell Secretome Product, for the Treatment of PCED at the 2022 ARVO...

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Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism

Posted: May 2, 2022 at 2:43 am

Results Presented Today at the Pediatric Endocrine Society’s 2022 Annual Meeting Results Presented Today at the Pediatric Endocrine Society’s 2022 Annual Meeting

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Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism

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Adverum Biotechnologies Presents Additional Efficacy and Safety Data from the OPTIC Trial of ADVM-022 in Wet AMD at the ARVO 2022 Annual Meeting

Posted: May 2, 2022 at 2:43 am

- Poster highlights analysis of baseline neutralizing antibodies to AAV.7m8 and impact on ADVM-022 efficacy and safety in OPTIC - - Reductions in mean annualized anti-VEGF injections ranged from 81% in all patients to 94% in those with NAbs <1:125 at 2 X 10^11 vg/eye -

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Adverum Biotechnologies Presents Additional Efficacy and Safety Data from the OPTIC Trial of ADVM-022 in Wet AMD at the ARVO 2022 Annual Meeting

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ObsEva Announces Appointment of Dr. Brandi Howard as Chief Clinical Officer

Posted: May 2, 2022 at 2:43 am

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

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ObsEva Announces Appointment of Dr. Brandi Howard as Chief Clinical Officer

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Idorsia’s new treatment QUVIVIQ (daridorexant) is now available in the US for adults living with insomnia

Posted: May 2, 2022 at 2:43 am

Allschwil, Switzerland & Radnor, PA, US – May 2, 2022Idorsia Ltd (SIX: IDIA) & Idorsia Pharmaceuticals, US Inc. today announced that QUVIVIQ™ (daridorexant) CIV 25 mg and 50 mg tablets are now commercially available for adult patients with insomnia, which is characterized by trouble with falling or staying asleep.

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Idorsia’s new treatment QUVIVIQ (daridorexant) is now available in the US for adults living with insomnia

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