Press Releases

Irrimax Corporation, manufacturer of Irrisept, announces new clearance from the U.S. Food and Drug Administration (FDA), making Irrisept the only self-contained irrigation system for antimicrobial wound lavage in the U.S. market. Today, more than 2,000 U.S. hospitals are using the Irrisept product totaling more than 2 million lifetime uses. As a result of the new clearance, Irrimax announces a new product name "Irrisept Antimicrobial Wound Lavage".  The indications fo

Amneal Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Bevacizumab, pursuant to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act). The biosimilar was developed in collaboration with mAbxience, a Spain-based biotechnology company. Bevacizumab is the biosimilar ve

The Alzheimer's Drug Discovery Foundation (ADDF) Diagnostics Accelerator today announced four new research investments for development of digital biomarkers for Alzheimer's diagnosis. These technology-based biomarkers will help identify subtle, yet pertinent psychological and behavioral changes that happen very early in people with Alzheimer's but may go unnoticed. "Smart phones, tablets and wearable devices can collect data from patients like never before and big d

InnoCare, a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its pan-FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma. InnoCare's ICP-192 is a highly selective pan-FGFR inhibitor targeting multiple solid tumors with FGFR gene aberrations. Currently, several clinical studies are ongoing in China and the United States

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Magenta Investments, a leading pharmaceutical and healthcare company that is part of an investment and industrial conglomerate in the United Arab Emirates (UAE), today announced a new agreement to distribute the Moderna COVID-19 Vaccine as well as Moderna’s updated variant booster candidates, once authorized, in the UAE in 2021 and 2022. “We welcome the opportunity to wo

Lipocine Inc., a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults. A pharmacokinetic ("PK&

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted an authorization application to Swissmedic for use of its COVID-19 vaccine in adolescents. “We are pleased to announce that we have submitted an authorization application for our COVID-19 vaccine with Swissmedic for use in adolescents in Switzerland,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are encourag

Global pharma major Lupin Limited (Lupin) through its CSR arm, the Lupin Foundation, is donating five oxygen generation plants to assist the states of Maharashtra, Madhya Pradesh and Gujarat in their ongoing fight against the COVID-19 pandemic. In preparation of ensuring India has a solid response for a potential third Covid wave, these five oxygen plants with a total capacity of 3840 cubic meters of oxygen per day have been donated to Madhya Pradesh, Maharashtra and Gujarat. The re

Bristol Myers Squibb and Acceleron Pharma Inc. announced the first data from the Phase 2 BEYOND study evaluating Reblozyl®(luspatercept-aamt), a first-in-class erythroid maturation agent, plus best supportive care in adult patients with non-transfusion dependent (NTD) beta thalassemia, were presented at the European Hematology Association (EHA) 2021 Virtual Congress as part of its Presidential Symposium (Abstract #S101). Results demonstrated that 77.7% of patients treated with Reblozyl ac

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received an amended Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allowing the company to market Sofia® Q, its latest addition to the Sofia® and Sofia® 2 line of Fluorescent Immunoassay Analyzers (FIA). Sofia Q features a sleek, miniaturized design that reads the same Sofia® S