SAB Biotherapeutics Announces Progress on U.S. FDA’s Phased Review of Company’s Groundbreaking DiversitAb™ Platform
- FDA has approved five of seven sections in a rolling submission required for a New Animal Drug Application (NADA)...
Pharmaceutical
Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE® From 80 mg Per Day To 100 mg Per Day
Concluded Positive FDA Type-C Meeting in Early May 2023 Company On Track to Submit an sNDA Early in the Third...
Phathom Pharmaceuticals Presents New Data at Digestive Disease Week® (DDW) 2023
Higher H. pylori eradication rates demonstrated with vonoprazan-based regimens vs. lansoprazole triple therapy, regardless of different baseline demographics and clinical...
Madrigal Pharmaceuticals Provides Corporate Updates and Reports First Quarter 2023 Financial Results
Resmetirom new drug application (NDA) filing on track for Q2 2023Resmetirom has received Breakthrough Therapy designation from FDA Multiple resmetirom...
ORYZON to Give Updates on Corporate Progress in May-June
BioEquity Europe 2023Foro Medcap BME 2023 VI Ibero-American Congress CEAPI 2023BIO International Conference 2023Jefferies Healthcare Conference 2023MidCap Paris 2023MADRID and...
FDA Removes Partial Clinical Hold on Salarius Pharmaceuticals’ Phase 1/2 Clinical Trial with Seclidemstat in Patients with Ewing Sarcoma
Decision Follows Review of Comprehensive Safety Data Package Submitted by the Company Salarius Plans to Meet with FDA to Discuss...
Kala Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update
-- Announced positive data from initial safety portion of CHASE Phase 2b clinical trial of KPI-012; now enrolling primary safety...
CymaBay Names Harish Shantharam Chief Financial Officer
Proven Leader in Building Financial Organizations to Prepare Company for Successful Commercialization Planning for Seladelpar Launch as it Completes Development...
TriLink BioTechnologies Introduces Latest mRNA Capping Technology: CleanCap® M6 analog
Newest cap analog product improves mRNA potency with greater protein expression, offers time and cost savings, and streamlines manufacturing to...
Ardelyx Presents Positive Data at DDW 2023 on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults
IBSRELA provides meaningful reduction of multiple abdominal symptoms Patient-reported outcomes are strongly correlated with IBS-C abdominal symptom score WALTHAM, Mass.,...
Adaptive Biotechnologies Announces FDA Acceptance of Genentech’s Investigational New Drug Application for the First Neoantigen-Directed T-Cell Therapy Product in Oncology
The T-Cell Therapy product candidate contains a neoantigen-specific T-cell receptor (TCR) identified and characterized through Adaptive’s TCR discovery platformSEATTLE, May...
Arbutus to Present at JMP Securities Life Sciences Conference
WARMINSTER, Pa., May 09, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical...
Verrica Pharmaceuticals Reports First Quarter 2023 Financial Results
New Drug Application for YCANTH™ (VP-102) PDUFA Goal Date of July 23, 2023 - Potential to Become Only FDA-approved Therapy...
Kura Oncology to Participate in JMP Securities Life Sciences Conference
SAN DIEGO, May 09, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing...
Radiopharm Theranostics Receives FDA Orphan Drug Designation for Trivehexin (RAD 301) in Pancreatic Cancer
Trivehexin radiopharmaceuticals being developed for imaging and treatment of cancers expressing αvβ6-integrinPancreatic ductal adenocarcinoma is primary indication due to high...
XOMA Reports First Quarter 2023 Financial Results and Provides Update on the Acceleration of its Differentiated Royalty Monetization Strategy
First quarter with incoming cashflows from two commercial assets Completed first royalty asset acquisition under new leadership EMERYVILLE, Calif., May...
MediWound Announces an Additional $10 Million Award from BARDA
Funding to support emergency stockpiling replenishment, pediatric indication submission, and expanded access treatment protocol extensionYAVNE, Israel, May 09, 2023 (GLOBE...
Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for...
Vivos Therapeutics Announces Additional Strategic Initiatives Aimed at Accelerating Anticipated Timeline for Cash Flow Positive Operations
Moss Adams LLP also appointed as new independent registered public accounting firmLITTLETON, Colo., May 09, 2023 (GLOBE NEWSWIRE) -- Vivos...
Biora Therapeutics to Report First Quarter 2023 Financial Results and Provide Corporate Update
SAN DIEGO, May 08, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic...