Pharmaceuticals, Biotechnology and Life Sciences
Pfizer and BioNTech said that the FDA is expected to make a decision on Emergency Use Authorization in the coming days after giving a positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data, which would make BNT162b2 the first COVID-19 vaccine available in the U.S.
—Low Dose Showed Positive Increases in Cardiac Protein Expression—Two Patients With >50% by IHC, One at Month 9 and One…
If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and…
Actinium Pharmaceuticals has reported 67% overall response rate in first cohort in Actimab-A Venetoclax combination trial in relapsed and refractory AML at ASH, which includes one complete response in patient with TP53 mutation and one partial response reported in patients with poor risk adverse cytogenetics with subtherapeutic dose of Actimab-A indicative of mechanistic synergy with venetoclax.
Piramal Pharma Solutions has said it plans to expand its facility in Riverview, Michigan, for which it will invest approximately $32 Million to add capacity and new capabilities in potent and non-potent API development and manufacturing.
Immunicum AB has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead…
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
COVID-19 is the medical emergency of the century. Since the pandemic began in December 2019, the new coronavirus, termed SARS-CoV-2 has caused havoc in almost every country, with more than 40 million proven cases of the disease termed COVID-19, including one million deaths.
CHICAGO–(BUSINESS WIRE)–Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use…
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new…