China's RemeGen's RC88 earns FDA Fast Track, heralding new hope for ovarian cancer patients

RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently dev...

January 15, 2024 | Monday | News
Pasithea Therapeutics' PAS-004 IND Application Accepted by FDA for Advanced Cancer Patient Evaluation.

-- Phase 1 dose escalation study in patients with MAPK pathway driven advanced solid tumors to begin in Q1 2024 – -- Initial readout expected as ear...

January 03, 2024 | Wednesday | News
Senhwa Biosciences Gains Taiwan FDA Approval for Silmitasertib Phase II Study in Viral-Associated Community-Acquired Pneumonia (CAP)

The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early...

December 27, 2023 | Wednesday | News
FDA Approves Label Update for Yescarta® CAR T-Cell Therapy with Overall Survival Data

Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtage...

December 22, 2023 | Friday | News
ALPCO Commercially Launches FDA-Cleared Calprotectin Assay

In July 2023, ALPCO unveiled the Calprotectin Immunoturbidimetric Assay at the American Association for Clinical Chemistry (now ADLM) annual meeting. This ...

December 20, 2023 | Wednesday | News
Neuronetics Receives 510(k) Clearance for NeuroSite™ Coil Placement Accessory

Neuronetics, Inc.  a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients...

December 19, 2023 | Tuesday | News
FDA Approves PADCEV® with KEYTRUDA® for Advanced Bladder Cancer

– PADCEV plus pembrolizumab approved based on groundbreaking EV-302 trial – – Confirmatory trial found PADCEV plus pembrolizumab nearly ...

December 18, 2023 | Monday | News
CHMP Greenlights Biogen's SKYCLARYS® for Rare Neurodegenerative Disease

Friedreich’s ataxia is a genetic, debilitating and life-shortening neuromuscular disease1 Milestone highlights Biogen’s growing portfolio in...

December 18, 2023 | Monday | News
FDA Establishes Advisory Committee for Genetic Metabolic Disease Treatments

Genetic metabolic diseases are conditions that disrupt an individual's metabolism, which is the chemical process responsible for converting food into energ...

December 13, 2023 | Wednesday | News
Candel Therapeutics' CAN-2409 Granted FDA Fast Track for Pancreatic Cancer

“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedS...

December 12, 2023 | Tuesday | News
RoslinCT to manufacture first-ever US FDA approved CRISPR-based gene therapy CASGEVY™

RoslinCT, a cell and gene therapy Contract Development and Manufacturing Organisation (‘CDMO’) dedicated to developing therapies for patients w...

December 11, 2023 | Monday | News
Cyprium Transfers CUTX-101 for Menkes Disease to Sentynl, a Zydus Lifesciences Subsidiary

Cyprium received $4.5 million payment upon closing and remains eligible to receive royalties and up to $129 million in aggregate development and sales mile...

December 07, 2023 | Thursday | News
Novartis' Fabhalta® (iptacopan) gains FDA approval as the first oral monotherapy for adults with PNH, showing superior hemoglobin improvement without transfusions.

Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inh...

December 06, 2023 | Wednesday | News
FDA Approves Agilent's PD-L1 IHC 22C3 pharmDx for Gastric Adenocarcinoma

Agilent  announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Ga...

November 29, 2023 | Wednesday | News

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