FDA Lifts Clinical Hold On Viking Therapeutics’ Rare Metabolic Disorder Study
The FDA has lifted the clinical hold placed on Viking Therapeutics Inc’s (NASDAQ:VKTX) trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). …
Capricor Therapeutics Announces First Patient Dosed In Pivotal Phase 3 Study Of CAP-1002 For Treatment Of Duchenne Muscular Dystrophy
Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select
The Daily Biotech Pulse: FDA Tentatively Approves Avadel’s Narcolepsy Drug, European Approval Broadens AstraZeneca’s Enhertu in Breast Cancer, Pharma Giants’ Earnings
Here's a roundup of top developments in the biotech space over the last 24 hours:
Novavax Announces Expanded Agreement With SK Bioscience To Manufacture Covid-19 Vaccine Containing Omicron Variant And Manufacture The Novavax Covid-19 Vaccine In Prefilled Syringes
Novavax Announces Expanded Agreement with SK bioscience to Manufacture COVID-19 Vaccine Containing Omicron Variant and Manufacture the Novavax COVID-19 Vaccine in Prefilled Syringes
GAITHERSBURG, Md., July 19,
Apellis Shares Climb As FDA Accepts Geographic Atrophy Candidate Submission Under Priority Review
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ (NASDAQ: APLS) New Drug Application (NDA) for the intravitreal pegcetacoplan.
The regulatory agency has assigned target action date of November 26, 2022.
Allena Pharmaceuticals Announces Completion Of Enrollment Of Cohorts A And B Of ALLN-346 Phase 2a Study 202 In Patients With Gout And Stages 2 And 3 Chronic Kidney Disease
Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) ("Allena" or the "Company"), a biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class,
Avadel Secures FDA Tentative Approval For Excessive Daytime Sleepiness (EDS) Candidate
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ: AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
AstraZeneca Announced Enhertu Approved in the EU for Patients With HER2-Positive Metastatic Breast Cancer Treated With One or More Prior Anti-HER2-based Regimens
Approval broadens indication for AstraZeneca and Daiichi Sankyo's Enhertu across Europe to earlier use in HER2-positive metastatic breast cancer. Based on ground-breaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of disease progression or death vs. trastuzumab emtansine (T-DM1).
Celcuity Announced FDA Breakthrough Therapy Designation for Gedatolisib for Treatment of HR+/HER2- Metastatic Breast Cancer
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for hormonally driven cancers, today announced that the U.S.
Acadia Seeks FDA Approval For Genetic Neurological Disorder Candidate
Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome.