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
Roche Reports Positive Phase III Results for Inavolisib Combo in Advanced HR+, HER2- Breast Cancer with PIK3CA Mutation

Phase III (INAVO120) results show that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the...

December 05, 2023 | Tuesday | News
Everest Medicines' Zetomipzomib IND Accepted in China

-- Everest plans to contribute to the ongoing global Phase 2b PALIZADE trial of zetomipzomib in active lupus nephritis –  -...

December 04, 2023 | Monday | News
Pfizer Reveals Positive Phase 2b Results for Obesity Drug Danuglipron

Danuglipron demonstrated mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks While most common adv...

December 04, 2023 | Monday | News
Junshi Biosciences' Toripalimab Application Accepted by Australia’s TGA

For the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and for toripalimab, as a single agent...

December 04, 2023 | Monday | 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
Mesoblast Seeks Orphan Drug Status for Rexlemestrocel-L in Treating Severe Congenital Heart Disease

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that it has filed for orphan ...

November 27, 2023 | Monday | News
Junshi Biosciences' VV116 COVID-19 Treatment Hits Lancet Infectious Diseases in Phase 3 Study Results

The paper presents final analysis results from a multicenter, double-blind, phase 3, randomized controlled study (NCT05582629) evaluating the efficacy and ...

November 24, 2023 | Friday | News
Genentech, NVIDIA Partner for Strategic AI Collaboration in Drug Discovery

- Collaboration leverages expertise in artificial intelligence from Genentech and NVIDIA to unlock scientific innovation and empower R&D at a sca...

November 22, 2023 | Wednesday | News
Certara Launches Simcyp™ Software to Enhance Drug Formulation Efficiency

Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation,  announced the introduction of Simcyp™ Biopharmaceutics software. It is designed...

November 22, 2023 | Wednesday | News
Hovione Acquires ExtremoChem for Enhanced Biopharmaceutical Stabilization and Delivery

Hovione has acquired ExtremoChem Lda, a start-up company with a portfolio of rare sugars, synthetic analogues of the natural molecules found in extremoph...

November 21, 2023 | Tuesday | News
Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer

"The NMPA approval of vebreltinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China. ...

November 17, 2023 | Friday | News
Vertex and CRISPR Therapeutics Granted Historic Approval for CASGEVY™, the World's First CRISPR/Cas9 Gene-Edited Therapy, by UK MHRA to Combat Sickle Cell Disease and Beta Thalassemia

 - First regulatory authorization of a CRISPR-based gene-editing therapy in the world – - CASGEVY is indicated for the treatment of sickle cell...

November 17, 2023 | Friday | News
Teva and Royalty Pharma Collaborate to Further Accelerate Olanzapine LAI Program

Royalty Pharma to provide R&D funding support of up to $125 million for the development of olanzapine LAI (TEV-‘749), a long-acting subcutaneou...

November 14, 2023 | Tuesday | News

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