Traders Circulate FDA Approval/Tentative Approval For TG Therapeutics ORIG-1
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761238
Aridis Pharmaceuticals To Discuss Topline Data From Phase 3 Study Of AR-301 During Corporate Update Call On January 25
Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, will host a conference
Unicycive Achieves Primary Endpoint In Pivotal Bioequivalence Study Of Renazorb
Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol
Renazorb's enhanced product profile features reduced pill burden and small, swallowable tablets, which may improve patient
PDS Biotech Reports Median Overall Survival Of 21 Months In Advanced, Refractory Cancer Patients Having Few Remaining Treatment Options With Reported Historical Survival Of 3-4 months
PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced expanded interim data
Minerva Neurosciences Confirms FDA’s Refuse Letter From Oct. 14, 2022 Remains In Effect
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that, following the Type
FDA Developing Regulating Pathways For Cannabis-Derived Ingredients In Foods, Supplements; Oversight Plans Expected In Few Months
In 2018, when Congress legalized cannabinoids, the FDA was put in charge of regulating the related products.
AstraZeneca Announced Calquence Approved in Japan for Adults with Treatment Naïve Chronic Lymphocytic Leukaemia
AstraZeneca's Calquence (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with treatment-naïve chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]). Calquence was previously approved in Japan for the treatment of adults with relapsed or refractory CLL.
AstraZeneca Announced Earlier Imfinzi, Imjudo Approved in Japan for 3 Cancers
AstraZeneca's immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types: advanced liver, biliary tract and lung.
Kala Pharmaceuticals Announces FDA Acceptance Of IND Application For KPI-012 For The Treatment Of PCED; Received Remaining $25M Investment Under Previously Announced Private Placement Financing
On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 --
-- Received remaining $25 million investment under previously announced private placement financing --
Biogen’s 2nd Alzheimer’s Antibody, BeiGene’s Cancer Drug Label Expansion, Adcom Test For Regeneron And More: January PDUFA Catalysts For Biotech Investors
Biopharma stocks were not immune to the broader market downturn seen for much of 2022.