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
Tofersen's FDA accelerated approval highlights blood neurofilament light chain's significance as surrogate endpoint in neurology trials

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery and breakthrough diagnostics through ultrasensitive biomarker detection, today...

April 26, 2023 | Wednesday | News
Avidity Biosciences' AOC 1044 gets FDA Fast Track for Duchenne Muscular Dystrophy treatment

Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotid...

April 25, 2023 | Tuesday | News
Virios Therapeutics gets FDA feedback on IMC-1 Phase 3 program for Fibromyalgia treatment

-Virios’ IMC-1 Phase 3 Proposed Program is Considered Acceptable based on Initial FDA Feedback Pending Review of the Final Chronic Toxicology Program...

April 25, 2023 | Tuesday | News
Forge Biologics Receives QP Declaration for AAV Gene Therapy Manufacturing in Europe

Forge Biologics, a leading manufacturer of genetic medicines, today announced that its manufacturing facility has successfully completed the audits necessa...

April 24, 2023 | Monday | News
FDA approves Roche's Polivy for untreated diffuse large B-cell lymphoma

Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive dise...

April 20, 2023 | Thursday | News
CDC Reports First-Ever Profound Autism Prevalence Data

The Centers for Disease Control and Prevention today reported 26.7 percent of people with autism spectrum disorder have "profound autism". It is the first ...

April 20, 2023 | Thursday | News
Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

"Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of prepara...

April 20, 2023 | Thursday | News
Otsuka and Lundbeck's Statement on FDA Advisory Committee Meeting for REXULTI in Alzheimer's Agitation

Otsuka Pharmaceutical Development & Commercialization, Inc., (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the Joint Meeting of the Psy...

April 18, 2023 | Tuesday | News
Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol

As disclosed in September 2022, Avenue received meeting minutes from the FDA regarding a Type A meeting conducted on August 9, 2022, for IV Tramadol. At th...

April 18, 2023 | Tuesday | News
HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer

Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED said, “The NMPA acceptance of our NDA for fruquintinib is a positive step towa...

April 18, 2023 | Tuesday | Regulatory

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