Author: Ragothaman Srinivasan

Pfizer PFE announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10…

The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s TCON lead asset envafolimab (KN035) for patients with locally advanced, unresectable or…

Akero Therapeutics AKRO revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic…

Lyra Therapeutics LYRA advanced into its Part 2 of the Phase 2 BEACON clinical trial of LYR-220 in adults with chronic rhinosinusitis (CRS) who have had a prior sinus surgery.…

Conformis CFMS has received 510(k) clearance from the U.S. Food and Drug Administration for its Actera Hip System. Actera utilizes an advanced tri-taper femur stem design that facilitates direct anterior…

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to GENFIT’s GNFT drug candidate GNS5611 (ezurpimtrostat) for the treatment of cholangiocarcinoma. The pre-clinical studies evaluating GNS561 has…

Adamis Pharmaceuticals ADMP announced that it has reached the initial planned enrollment target in the ongoing U.S. Phase 2/3 clinical trial investigating Tempol as a treatment for COVID-19. The Phase 2/3…

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ SPPI lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. ROLVEDON (eflapegrastim-xnst)…

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ SPPI lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. Spectrum…

The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ RVNC lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severecfrown lines (glabellar…

Silence Therapeutics  SLN announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead candidate SLN124 for the treatment of polycythemia vera (PV). SLN124…

The European Commission has granted an orphan drug designation (ODD) to Viracta’s VIRX lead drug combination nanatinostat and valganciclovir (Nana-val) for the treatment of peripheral T-cell lymphoma (PTCL). The Nana-val…

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s PFE lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to…

The U.S. Food and Drug Administration (FDA) has approved expanded use of Vertex’s VRTX lead asset ORKAMBI (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) ages 12 to <24 months.…

The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review Y-mAbs Therapeutics’ YMAB Biological License Application (BLA)…

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ NTLA lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in…

Amgen AMGN announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib) in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), the study met…

The U.S. Food and Drug Administration (FDA) has reviewed Inhibikase Therapeutics’ IKT Investigational New Drug (IND) application and issued a Study May Procced (SMP) letter for its drug candidate IkT-001Pro…

Results indicate significant decrease in cocaine craving in a sub-group that received the treatment TEL AVIV, Israel, Aug. 24, 2022 (GLOBE NEWSWIRE) — SciSparc Ltd. SPRC, a specialty clinical-stage pharmaceutical…

Patients always have hope if their cancers are detected early. Thanks to advanced research and therapies, the earlier the cancer is diagnosed and treated, the better the chance of it being cured.…