
FDA grants Bristol Myers Squibb accelerated approval for Zenbexus (iberdomide), a CELMoD agent, for multiple myeloma | Gif: Brent Rambo on Giphy
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
FDA grants Bristol Myers Squibb accelerated approval for Zenbexus (iberdomide), a CELMoD agent, for multiple myeloma
Small molecule, cancer, CELMoD degrader, multiple myeloma, relapsed or refractory multiple myeloma, combination therapy - Read more
Enigma Biomedical USA wins FDA approval for TAUKLARIFY (florquinitau F 18) targeting tau pathology in Alzheimer's disease evaluation
Diagnostic imaging, neurological, PET imaging, Alzheimer's disease, tau protein, radiodiagnostic agent - Read more
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✅ More Good News ✅
THE GOOD
Fundraises
Vogenx raises $81.3M IPO, clinical-stage biopharma targeting metabolic serious diseases
Clinical-stage, metabolic disease, small molecule, biopharmaceutical - Read more
Aptevo Therapeutics raises $4.5M via warrant exercise and PIPE for working capital
Clinical-stage, immuno-oncology, multispecific antibody, bispecific - Read more
MagicRNA closes hundreds of millions yuan Series B, advancing in vivo CAR-T immunotherapy platform
In vivo CAR-T, mRNA delivery, autoimmune, cell therapy, LNP platform, clinical-stage - Read more
Zentalis Pharmaceuticals plans $80.5M public offering to fund oncology clinical trials and pre-commercial activities
Oncology, small molecule, clinical-stage, biomarker discovery, ovarian cancer - Read more
BridgeBio Pharma plans secondary offering of 5M shares by existing shareholder KKR
Genetic conditions, small molecule, rare disease, commercial-stage - Read more
THE GOOD
Mergers & Acquisitions
Skye Bioscience to acquire Redx Pharma in deal backed by $125M in combined financings
Small molecule, fibrotic disease, major transaction, financial - Read more
THE GOOD
Regulatory
Capricor Therapeutics soars after FDA greenlights amendment to DMD cell therapy approval application
Cell therapy, rare disease, regulatory, financial - Read more
Neurocrine Biosciences defends Vykat XR safety amid advocacy groups' concerns over serious adverse events
Small molecule, rare disease, safety, regulatory - Read more
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❌ The Bad News ❌
THE BAD
Earnings & Finances
Karyopharm Therapeutics faces potential debt default next month as cash reserves near depletion
Small molecule, oncology, financial, strategic - Read more
THE BAD
Lawsuits
Cytokinetics files patent complaint against Bristol Myers Squibb over MYQORZO heart disease therapy infringement claims
Small molecule, cardiovascular, competitive, regulatory - Read more
Bristol Myers Squibb faces revived Celgene shareholder lawsuit over $6B CVR Breyanzi agreement
CAR-T, oncology, contingent value rights, financial - Read more
THE BAD
Market Reports
AstraZeneca's Baxfendy fails ICER cost-effectiveness threshold at $10,800 annual list price
Small molecule, cardiovascular, regulatory, competitive - Read more
THE BAD
Regulatory
Amgen's Tavneos loses EU approval after regulators cite "serious breaches" in pivotal trial data
Small molecule, rare disease, regulatory, financial, operational - Read more
THE BAD
Strategic Plans
MapLight Therapeutics pauses preclinical programs, raises $150M to advance ML-007C-MA toward phase 3 schizophrenia trial
Small molecule, neurological, strategic, cost reduction - Read more
You’re all caught up on the latest Pharma & Biotech News!
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