An FDA advisory committee voted against Lexicon Pharmaceuticals' Zynquista for treating adults with type 1 diabetes and chronic kidney disease.

Recce Pharmaceuticals has obtained a key patent approval in China, marking a significant milestone for the company's intellectual property portfolio.

Marinus Pharmaceuticals anticipates Phase 3 TrustTSC trial results for ZTALMY® in tuberous sclerosis complex (TSC) in Q4 2024, with NDA filing targeted for April 2025.

Faron Pharmaceuticals has identified the final patient for its BEXMAB Phase II dose optimization study in refractory or relapsed myelodysplastic syndrome (r/r MDS).

Milestone Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for etripamil nasal spray, a potential treatment for paroxysmal supraventricular tachycardia (PSVT).

NRx Pharmaceuticals is developing NRX-101, an FDA-designated Breakthrough Therapy for treatment-resistant bipolar depression with suicidality, with plans to file for Accelerated Approval.

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Longboard Pharmaceuticals has initiated a global Phase 3 trial, DEEp SEA, to evaluate bexicaserin for treating seizures associated with Dravet syndrome.

The FDA has approved Nexus Pharmaceuticals' Methylene Blue Injection, USP, for treating acquired methemoglobinemia, a rare blood disorder.

The FDA granted accelerated approval to Ziihera (zanidatamab) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer in adults.

Faron Pharma's bexmarilimab has been granted an Innovation Passport by the UK MHRA for relapsed/refractory Myelodysplastic Syndrome (r/r MDS).

• Camber Pharmaceuticals has successfully implemented comprehensive DSCSA compliance measures, achieving 100% aggregation from bottle to pallet level for pharmaceutical product tracking. • The company has demonstrated exceptional performance in customer testing with 95-100% success rates, utilizing TraceLink's Verification Routing Services for product authentication since 2022. • In preparation for the November 2024 DSCSA deadline, Camber is increasing inventory levels to support customers whose other suppliers may not achieve full compliance.

Island Pharmaceuticals has completed dosing in Phase IIa of the PROTECT trial, evaluating ISLA-101 for dengue fever prevention.

Madrigal Pharmaceuticals reported $62.2 million in net revenues for Q3 2024, driven by the U.S. launch of Rezdiffra for NASH/MASH.

Madrigal Pharmaceuticals reported $62.2 million in net revenues for Q3 2024, driven by the U.S. launch of Rezdiffra (resmetirom) for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH).

Recursion's REC-3565, a MALT1 inhibitor for B-cell malignancies, has been cleared for a Phase 1 clinical trial by the UK MHRA, addressing unmet needs in hematologic cancers.

Alebund Pharmaceuticals, a biopharmaceutical company specializing in innovative therapies for renal diseases, has successfully completed a Series C financing round of RMB 550 million. This funding will support the development and commercialization of its renal disease pipelines and accelerate clinical-stage programs.

Telix Pharmaceuticals' brain cancer imaging agent Pixclara (TLX101-CDx) received a rejection from the FDA, which requested additional clinical evidence before approval.

Longboard Pharmaceuticals has initiated the Phase 3 DEEp OCEAN study to evaluate bexicaserin for seizures associated with Developmental and Epileptic Encephalopathies (DEEs).

The FDA has granted Fast Track Designation to Clarity Pharmaceuticals' 64Cu-SAR-bisPSMA for PET imaging of prostate cancer lesions in patients with biochemical recurrence. This second Fast Track Designation strengthens the company's position in the growing US$2 billion PSMA PET diagnostics market and could accelerate the path to regulatory approval.