Catalent Strengthens Cryogenic Capabilities in Shiga, Japan, Facility for Cell and Gene Therapy

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational ...

May 25, 2023 | Thursday | News
FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human ...

May 24, 2023 | Wednesday | News
Rakuten Medical Initiates Global Phase 3 Trial of Alluminox™ Treatment for Head and Neck Cancer in India

The Company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical...

May 23, 2023 | Tuesday | News
Thermo Fisher Scientific's Immunoassays Receive FDA Clearance for Preeclampsia Risk Assessment

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleare...

May 20, 2023 | Saturday | News
10x Genomics Wins Permanent Injunction Against NanoString's CosMx Products

10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, today announced that it has won an injunction in its patent litigation ...

May 18, 2023 | Thursday | News
FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," said Janet Maynard, M.D., M.H.S., direct...

May 15, 2023 | Monday | News
MediciNova granted new patent for MN-166 (ibudilast) in Europe for microorganism infection

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than February 2039. The allowed claims cover MN...

May 15, 2023 | Monday | News
China NMPA Approves TYVYT® Combo for EGFR-mutated NSCLC Patients Who Progressed After EGFR-TKI Therapy

This is the seventh NMPA-approved indication of TYVYT® (sintilimab injection). The first six indications of TYVYT® (sintilimab injection) are inclu...

May 10, 2023 | Wednesday | News
China Approves KN026 + Chemotherapy Phase III Study for Breast Cancer Treatment

Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. jointly announced that the IND application was approved in China for t...

May 09, 2023 | Tuesday | News
BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the China National Medical Products Administration (NMPA)...

May 08, 2023 | Monday | News
New ACR Breast Cancer Screening Guidelines call for earlier and more-intensive screening for high-risk women

Other Notable Updates:   New American College of Radiology® (ACR®) breast cancer screening guidelines now call for all women &mdas...

May 04, 2023 | Thursday | News
Nanox.ARC Imaging System Receives FDA Clearance, Pioneering a New Era in Medical Imaging

NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has received a ...

May 02, 2023 | Tuesday | Regulatory
Amicus Therapeutics Receives Positive CHMP Opinion for Opfolda® (miglustat) for Late-Onset Pompe Disease

European Commission Approval of Opfolda and Commercial Launch of Pombiliti® + Opfolda® Anticipated in 3Q 2023   Upon Approval, Pombiliti + O...

April 27, 2023 | Thursday | News
Roche's Columvi Gets CHMP Nod for Fixed-Duration Use in Diffuse Large B-cell Lymphoma

The recommendation is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete r...

April 27, 2023 | Thursday | Regulatory

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