Vertex Pharmaceuticals Awaits FDA Decision on Suzetrigine for Acute Pain
The FDA is expected to decide on the approval of suzetrigine for acute pain treatment by January 30, potentially expanding Vertex's market beyond cystic fibrosis.
Recce Pharmaceuticals Advances Clinical Trials and Secures A$12.5 Million Funding
Recce Pharmaceuticals has made significant strides in its clinical trials, marking progress in its anti-infective programs.
Jazz Pharmaceuticals CEO Bruce Cozadd Announces Retirement After 15-Year Tenure
Jazz Pharmaceuticals CEO Bruce Cozadd has announced his retirement after leading the company since 2009, though he will remain as board chairman after the transition.
Eton Pharmaceuticals Secures Second Patent for Liquid Hydrocortisone Formulation ET-400
Eton Pharmaceuticals has been granted a second patent for ET-400, its proprietary liquid hydrocortisone formulation, extending protection through 2043.
Recce Pharmaceuticals' RECCE 327 Gel Shows Promise in Phase II ABSSSI Trial
Recce Pharmaceuticals' RECCE 327 Topical Gel (R327G) demonstrates a favorable safety profile and encouraging efficacy in treating Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
GSK Partners with Cloud Pharmaceuticals to Accelerate Drug Discovery Through AI Technology
GlaxoSmithKline has entered a strategic collaboration with Cloud Pharmaceuticals to leverage AI-driven technology for designing novel small-molecule agents, marking Cloud's first major pharma partnership.
FDA Issues Complete Response Letter for Milestone Pharmaceuticals' Etripamil Nasal Spray
The FDA has issued a Complete Response Letter for Milestone Pharmaceuticals' Cardamyst (etripamil) nasal spray, citing chemistry, manufacturing, and controls issues rather than safety or efficacy concerns.
China Streamlines Local Manufacturing for Foreign Pharmaceuticals
China is enhancing its regulatory framework to encourage local pharmaceutical manufacturing, particularly for drugs already approved as imports.
FDA Rejects Vanda Pharmaceuticals' Fanapt for Gastroparesis
The FDA has declined to approve Vanda Pharmaceuticals' supplemental New Drug Application (sNDA) for Fanapt (iloperidone) in treating gastroparesis, a stomach condition characterized by delayed gastric emptying.
Appili Therapeutics Advances ATI-1801 Development for Cutaneous Leishmaniasis with FDA Alignment
Appili Therapeutics has secured FDA alignment on development requirements for ATI-1801, a novel topical paromomycin formulation for treating cutaneous leishmaniasis, paving the way for NDA submission.
Recce Pharmaceuticals' Phase II Trial of R327G for ABSSSI Reaches Halfway Enrollment
Recce Pharmaceuticals has dosed 15 patients in its Phase II trial of RECCE® 327 topical gel (R327G) for acute bacterial skin and skin structure infections (ABSSSI).
LB Pharmaceuticals' LB-102 Shows Promise in Phase 2 Trial for Schizophrenia
LB Pharmaceuticals' LB-102 met its primary endpoint in a Phase 2 trial, significantly reducing PANSS total scores in schizophrenia patients.
X4 Pharmaceuticals Announces Positive Phase 2 Results for Mavorixafor in Chronic Neutropenia
X4 Pharmaceuticals reported positive Phase 2 clinical data for mavorixafor in chronic neutropenia (CN), showing increased neutrophil counts.
Stifel Initiates Coverage on ORIC Pharmaceuticals with Buy Rating and $20 Target
Stifel has initiated coverage on ORIC Pharmaceuticals with a Buy rating and a $20 price target, highlighting the company's potential in prostate cancer treatments, especially its ORIC-944 product expected to enter phase 3 trials in 2025. ORIC Pharmaceuticals is noted for its innovative approach to treating metastatic castration-resistant prostate cancer, with ORIC-944 utilizing PRC2 inhibition in combination with androgen receptor pathway inhibitors.
Cosmo Pharmaceuticals Reports Progress in Clinical Trials and Strategic Growth in 2024
Cosmo Pharmaceuticals has announced significant progress in its clinical trials for Bile Acid Diarrhea, Distal Ulcerative Colitis, and Solid Tumors, alongside strategic growth initiatives in 2024. The company is advancing its pipeline with a strong cash position and a commitment to innovation and operational excellence.
Phio Pharmaceuticals Completes Enrollment in Phase 1b Trial of PH-762 for Skin Cancers
Phio Pharmaceuticals has completed enrollment in the second cohort of its Phase 1b dose-escalating clinical trial of PH-762.
Tonix Pharmaceuticals' TNX-102 SL Shows Promise in Fibromyalgia Treatment
Tonix Pharmaceuticals presented Phase 3 RESILIENT study data, revealing TNX-102 SL significantly reduced fibromyalgia pain versus placebo.
Corvus Pharmaceuticals' Soquelitinib Shows Promise in Phase 1 Atopic Dermatitis Trial
Corvus Pharmaceuticals' Phase 1 trial of soquelitinib for atopic dermatitis shows a favorable safety and efficacy profile.
Adial Pharmaceuticals Receives Milestone Payment as Adovate Launches Phase 1 Trial for Novel Asthma Therapy
Adial Pharmaceuticals has received a six-figure milestone payment from Adovate following the initiation of a Phase 1 clinical trial for ADO-5030, a novel adenosine receptor antagonist targeting asthma.
FDA Approves Nilotinib Tablets (Danziten) Without Mealtime Restrictions for CML
The FDA has approved nilotinib tablets (Danziten) for Philadelphia chromosome-positive chronic myeloid leukemia (CML) patients, offering a new treatment option.