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Tarsus Pharmaceuticals Advances Ocular Rosacea Program and Accelerates XDEMVY Launch

1/13/2025

Tarsus Pharmaceuticals is set to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) in the second half of 2025 for treating ocular rosacea.

TAHO Pharmaceuticals Initiates Phase III Trial of Apixaban Oral Dissolving Film

11/19/2024

TAHO Pharmaceuticals has begun a Phase III clinical trial in the U.S. for TAH3311, an oral dissolving film (ODF) formulation of apixaban.

TAHO Pharmaceuticals Initiates Phase III Trial of Apixaban Oral Dissolving Film

11/19/2024

TAHO Pharmaceuticals has begun a U.S. Phase III clinical trial for TAH3311, an oral dissolving film (ODF) formulation of apixaban, a direct factor Xa inhibitor.

Tonix Pharmaceuticals Bolsters Leadership Team and Provides Update on TNX-102 SL

12/3/2024

Tonix Pharmaceuticals has appointed Bradley Raudabaugh as Vice President of Marketing and Errol Gould, Ph.D., as Vice President of Medical Affairs to support the potential launch of TNX-102 SL.

Kiora Pharmaceuticals Receives IND Approval for KIO-301 Phase 2 Retinitis Pigmentosa Trial

10/29/2024

Kiora Pharmaceuticals received IND approval to begin a Phase 2 trial (ABACUS-2) of KIO-301 for vision restoration in retinitis pigmentosa patients.

Suven Pharmaceuticals and Cohance Lifesciences Merger Approved, Creating $1 Billion CDMO Powerhouse

4/25/2025

The National Company Law Tribunal and Department of Pharmaceuticals have granted final approval for the merger of Suven Pharmaceuticals and Cohance Lifesciences, effective May 1, 2025.

MELT-300 Shows Positive Phase 3 Results for Cataract Surgery Sedation

11/20/2024

MELT-300, a non-IV, non-opioid sublingual tablet, demonstrated positive topline efficacy in a Phase 3 trial for procedural sedation during cataract surgery.

Glenmark Expands Injectable Portfolio with Acetylcysteine Acquisition and US Launch

3/3/2025

Glenmark Pharmaceuticals has acquired and launched Acetylcysteine Injection (6 gm/30 mL) in the US market, expanding its presence in the hospital segment through the ANDA acquisition from Aspen Pharma USA.

Alys Pharmaceuticals Advances First Genetic Medicine for Dermatology with Phase 2a Trial IND Clearance

2/4/2025

Alys Pharmaceuticals has received FDA IND clearance to initiate a Phase 2a clinical trial for their pioneering genetic medicine program in dermatology, marking a significant milestone in the field.

Phathom Pharmaceuticals Presents New VOQUEZNA® Data at ACG 2024

10/27/2024

Phathom Pharmaceuticals presented data at ACG 2024 highlighting VOQUEZNA's efficacy for Non-Erosive GERD, including on-demand use and nocturnal symptom relief.

Tonix Pharmaceuticals Submits NDA for TNX-102 SL for Fibromyalgia Treatment

9/24/2024

Tonix Pharmaceuticals has submitted an NDA to the FDA for TNX-102 SL, a non-opioid analgesic, seeking approval for fibromyalgia treatment.

Marinus Pharmaceuticals' Ganaxolone Fails Phase 3 Trial for Tuberous Sclerosis Complex

10/24/2024

Marinus Pharmaceuticals' Phase 3 TrustTSC trial of oral ganaxolone for tuberous sclerosis complex (TSC)-associated seizures did not meet its primary endpoint.

Crinetics Pharmaceuticals' Atumelnant Shows Promise in Phase 2 Trial for Congenital Adrenal Hyperplasia

11/22/2024

Crinetics Pharmaceuticals' atumelnant demonstrated significant A4 reductions in a Phase 2 trial, positioning it favorably against existing treatments for congenital adrenal hyperplasia (CAH).

ORIC Pharmaceuticals Announces Promising Early Data for ORIC-944 and Collaboration for ORIC-114

1/13/2025

ORIC Pharmaceuticals reported encouraging early data from a Phase 1b trial of ORIC-944 combined with apalutamide in metastatic castration-resistant prostate cancer (mCRPC).

Tonix Pharmaceuticals Presents Promising Data on Mpox Vaccine Candidate TNX-801

9/9/2024

Tonix Pharmaceuticals' TNX-801, a horsepox-based vaccine, demonstrates efficacy in protecting animals against lethal mpox challenge, supporting its potential as a single-dose mpox vaccine.

Hemogenyx's FLT3 Assay Ready for HEMO-CAR-T Phase I Trials in AML

9/9/2024

Hemogenyx Pharmaceuticals has developed a clinical-grade assay to assess FLT3 protein expression in acute myeloid leukemia (AML) cells.

CNS Pharmaceuticals Secures Orphan Drug Designation for TPI 287 in Brain Cancer Treatment

5/13/2025

CNS Pharmaceuticals has successfully acquired Orphan Drug Designation from Cortice Biosciences for TPI 287, a novel abeotaxane with potential to cross the blood-brain barrier for treating brain tumors.

Accropeutics' RIPK2 Inhibitor AC-101 Advances in Ulcerative Colitis Trials

12/13/2024

Accropeutics' AC-101, a RIPK2 inhibitor, received FDA clearance for a Phase II clinical trial to treat moderate-to-severe Ulcerative Colitis (UC).

Enanta Pharmaceuticals Awaits Phase II Zelicapavir Data for RSV

10/7/2024

• Enanta Pharmaceuticals' Zelicapavir (EDP 938) is in Phase II trials (RSVPEDs and RSVHR) targeting RSV in pediatric and high-risk adult populations. • RSVPEDs, a Phase II trial in RSV-infected children aged 28 days to 3 years, has completed enrollment, with topline data expected in Q4 2024. • EDP-323, another RSV drug candidate from Enanta, showed statistically significant reductions in viral load and clinical symptoms in a Phase IIa human challenge study. • Enanta's financial stability is supported by $272.6 million in cash, cash equivalents, and marketable securities as of June 30, 2024, along with royalties from AbbVie's MAVYRET/MAVIRET.

Alembic Pharmaceuticals Receives FDA Approval for Pantoprazole Sodium Injection to Treat GERD

4/3/2025

Alembic Pharmaceuticals has secured final USFDA approval for Pantoprazole Sodium for Injection (40 mg/vial), therapeutically equivalent to Wyeth's Protonix I.V. for Injection.

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