Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 April 08, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission o

- 8.9 Months Median Overall Survival (mOS) in Patients with AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 mOS in All Relapsed or Refractory to Venetoclax-Based Regimens Patients; Surpassing Historical Benchmark of 2.5 Months - - Overall Response Rate (ORR) of 67% Achieved in Patients with AML-MRC (Target Patient Population of SLS009 in r/r AML) – Exceeding Targeted 20% ORR - - Trial Continues with Full Data and FDA Regulatory Path Feedback Expected in 1H 2025 – April 08, 2025 -- SELLAS L

April 08, 2025 -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria being held from April 11-15, 2025. SCY-247 is being developed to address systemic fungal diseases

FDA action allows for unrestricted distribution of EGRIFTA SV®, removing uncertainty with respect to all manufactured batches PAS approval follows recent FDA approval of new formulation, EGRIFTA WR™ April 08, 2025 -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Prior Approval Supplement (PAS) to the supplemental bio

EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically debilitating Preeclampsia, a serious obstetric complication, is a leading cause of near-term morbidity and mortality for mothers and their babies, and can lead to long-term consequences for both An investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1, a key pathogenic mediator of preeclampsia, in the placenta CBP-4888

April 08, 2025 -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, is supporting key educational programs and initiatives throughout the month of April in recognition of Esophageal Cancer Awareness Month. The Company is proudly collaborating with the Esophageal Cancer Action Network (ECAN), the American Foregut Society (AFS) and The Gut Doctor PodcastLLC to promote esophageal cancer prevention, education and advocacy. “As eso

April 08, 2025 -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced the completion of enrollment in its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse for the treatment of oral lichen planus (OLP). The Phase 2a trial has now fully enrolled participants across all three dose cohorts (0.25 mg, 0.50 mg and

–EFFICACY: 92% median reduction in disabling seizures during 7-12-month efficacy endpoint period, and 80% (4/5) of patients responding with >75% seizure reduction in Cohort 1. –DURABILITY: All responders (4/4) in Cohort 1 continue to have durable seizure control for 18-24 months after a single-dose of NRTX-1001. –COGNITION AND QUALITY OF LIFE: All patients (5/5) in Cohort 1 had significantly improved quality-of-life test scores, with no patient experiencing persistent decline in cognition. –

TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two pivotal double-blind randomized Phase 3 studies FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia If approved by FDA, it would become the first member of a new c

April 07, 2025 -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $150 million. “We have reached another key milestone with the closing on the sale of our PRV, which we received following the successful approval of MIPLYFFATM (arimoclomol) from the U.S. Food and