Rhythm Pharmaceuticals announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for RM 493 (setmelanotide) for the treatment of pro-opiomelanocortin (POMC)… read more.
Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO… read more.
Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic… read more.
Zynerba Pharmaceuticals announced top line results from the 14-week pivotal CONNECT-FX study of Zygel (cannabidiol) which assessed its efficacy and safety as a treatment in for behavioral symptoms… read more.
Pfizer announced that the European Commission approved Daurismo (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly… read more.
Achieve Life Sciences announced the successful topline results from the New Zealand RAUORA Phase III non-inferiority clinical trial comparing cytisinicline to Chantix (varenicline) in Maori (indigenous New Zealanders)… read more.
RedHill Biopharma Ltd. announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s Clinical Trial Authorization application to commence a Phase II/III study… read more.
Cancer Prevention Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for CPP 1X/sul for treatment of adults with familial adenomatous polyposis (FAP)…. read more.
Heron Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the FDA on June 26, 2020 regarding its New Drug Application (NDA) for HTX 011… read more.
Iterum Therapeutics announced topline results from its phase III SURE 1 clinical trial of sulopenem for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel… read more.
Kiniksa Pharmaceuticals announced that the Phase III RHAPSODY trial showed that rilonacept achieved its primary and all major secondary efficacy endpoints in patients with recurrent pericarditis. Results show… read more.
Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of… read more.
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