US FDA approves anti-CD38 therapy, Sarclisa in combo with …
WEB1 day ago · The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant ...
WHO & MDBs kick off US$ 1.5 bn primary health financing …
WEB1 hour ago · Execution is starting under the new Health Impact Investment Platform on the first country health investment plans turning original commitment into operational reality. The landmark partnership between Multilateral Development Banks (MDBs), the World Health Organization (WHO) and low- and middle ...
US FDA approves AstraZeneca’s needle-free nasal spray, FluMist …
WEB2 days ago · Cambridge, UK. Monday, September 23, 2024, 09:00 Hrs [IST] AstraZeneca, a global, science-led biopharmaceutical company, announced that FluMist has been approved in the US as the only self-administered influenza vaccine. FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a ...
EMA’s human medicines committee recommends approval of …
WEB5 hours ago · GSK plc announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive ...
Roche introduces cobas Respiratory flex test to use its TAGS …
WEB2 hours ago · Roche announced the launch of the cobas Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined with colour ...
Astellas Pharma announces US FDA listing of DIGITIVA for the …
WEB5 days ago · Tokyo. Friday, September 20, 2024, 11:00 Hrs [IST] Astellas Pharma Inc. announced that DIGITIVA, a non-invasive digital health solution for heart failure management, has been listed with the US Food and Drug Administration (FDA). DIGITIVA is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510 (k) premarket submission.
US FDA grants Emergency Use Authorization to Novavax 2024 …
WEBSep 2, 2024 · Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced the Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for active immunization to ...
News - Pharmabiz.com
WEB2 days ago · Pharmabiz.com - India's most comprehensive online pharma news service. It provides updates on Indian pharma industry, allied sectors like hospitals & diagnostic services,pharma tenders, pharma projects, pharma export & import, pharma laws & documents, pharma policies, pharma events, pharma company profiles, pharma studies, pharma marketing.
Pfizer, BioNTech receive US FDA approval & authorization for …
WEBSaturday, August 24, 2024, 09:00 Hrs [IST] Pfizer Inc. and BioNTech SE announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (Covid-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 …
Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
WEBFriday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...
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