Drug Approval | February 20, 2022
Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy
Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear
Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear
Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation
Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data
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