Cranbury Pharmaceuticals Gains FDA Approval for Generic Emflaza® Oral Suspension (Deflazacort) for Duchenne Muscular Dystrophy
Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, has announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for the first…
New Thermo Scientific Heracell Incubators Propel the Future of Fully Automated Labs
To advance workflow automation in cell therapy production, Thermo Fisher Scientific has launched the Thermo Scientific™ Heracell™ VIOS™ 250i AxD CO2 Incubators. These pioneering CO2 incubators are tailored for integration…
Veteran Pharma Oncology Developer Krista McKerracher Appointed as Genialis Board Chairperson
The RNA-biomarker company announced today the appointment of Krista McKerracher as Chairperson of the Board of Directors. McKerracher is a seasoned biopharmaceutical leader with a passion for bringing new medicines…
Sibylla Biotech and MD Anderson Forge Strategic Partnership to Advance Small-Molecule Protein Degrader Development
Sibylla Biotech and The University of Texas MD Anderson Cancer Center have announced a strategic collaboration to discover and develop novel small-molecule cancer therapies called Folding Interfering Degraders (FIDs). These…
Tagrisso Receives US Priority Review for Unresectable Stage III EGFR-Mutated Lung Cancer
AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso has been accepted and granted Priority Review in the US for treating adult patients with unresectable, Stage III epidermal growth factor receptor-mutated…
Roche’s Four-in-One Test for COVID-19, Flu, and RSV Gets FDA EUA
Roche announced that the U.S. FDA has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This automated multiplex real-time PCR assay…
EU Approves Roche’s Alecensa as First Adjuvant Therapy for ALK+ Early-Stage Lung Cancer
The European Commission has approved Alecensa® (alectinib) monotherapy as an adjuvant treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who are at high risk…
MAIA Biotech’s Latest Advancements: Yearly Success and Breakthroughs in Cancer Treatment
MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, has announced its highlights and key achievements for the year so far, along…
Geron’s RYTELO™ Approved by FDA for Lower-Risk MDS Treatment
Geron Corporation (Nasdaq: GERN), a biopharmaceutical company dedicated to revolutionizing blood cancer treatment, has received FDA approval for RYTELO™ (imetelstat). This approval is specifically for treating adult patients with low-…
FDA Greenlights AREXVY by GSK: First RSV Vaccine for High-Risk Adults 50-59
GSK plc announced today that the US Food and Drug Administration (FDA) has given the green light to AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV…
FDA Clears GSK’s AREXVY for Adults 50-59: Expanded RSV Vaccine Use
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted approval for AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) to prevent RSV lower respiratory…
FDA Approval Validates MAIA Biotechnology’s Telomere-Targeting Therapy Using a Telomerase Inhibitor
MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage enterprise dedicated to developing telomere-targeting immunotherapies for cancer, has celebrated the validation of clinical and regulatory pathways for effective therapies leveraging the…