FDA - Spark Newswire

1 minute read

Tonix Pharma Fibromyalgia Treatment Associated with Improvement in Pain, Sleep, Fatigue

Today, 2:24 AM

Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has announced the poster presentation of previously reported results from its Phase 3 RELIEF trial evaluating the TNX-102…

TNXP

1 minute read

Updated Analysis Show Seagen’s Tukysa Extended Median OS to Two Years with Benefits Maintained in Breast Cancer

By Vandana Singh

Today, 2:24 AM

Seagen Inc (NASDAQ:SGEN) has announced that improvements in overall survival (OS) and progression-free survival (PFS) were maintained with long-term follow-up from…

SGEN

5 minute read

The Daily Biotech Pulse: Merck Completes Organon Spin-Off, Auris Repositions As RNA Therapeutic Company With Trasir Purchase, Replimune’s Readout

By Shanthi Rexaline

Today, 2:24 AM

Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs June 2)

AMYT

1 minute read

Oric Pharma’s ORIC-101 Shows Tumor Regression, Prolonged Stable Disease in Multiple Heavily Pretreated Tumors

By Vandana Singh

Today, 2:24 AM

Oric Pharmaceuticals Inc (NASDAQ:ORIC) has announced initial data from an ongoing Phase 1b study evaluating ORIC-101 in combination with nab-paclitaxel, in…

ORIC

1 minute read

Eli Lilly-Innovent Biologics Score Expanded Use Approval of Tyvyt n Lung Cancer Patients In China

By Vandana Singh

Today, 2:24 AM

The National Medical Products Administration (NMPA) of China has approved Innovent Biologics Inc (OTC:IVBXF) and Eli Lilly And Co’s (NYSE:LLY) Tyvyt (sintilimab injection)…

IVBIY

2 minute read

Monopar Announces New Drug Candidate, MNPR-202; Says Enters Into Collaboration Agreement With National University Of Singapore For Preclinical Evaluation In Cancer

By Benzinga Newsdesk

Today, 2:24 AM

Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of

MNPR

1 minute read

Amryt Pharma’s Oleogel-S10 Application Gets FDA Priority Review Tag for Skin Blistering Disorder

By Vandana Singh

Today, 2:24 AM

The FDA has granted priority review status to Amryt Pharma’s (NASDAQ:AMYT) marketing application seeking approval for Oleogel-S10 to treat Epidermolysis Bullosa (EB).…

AMYT

2 minute read

FDA
News

Hoth Therapeutics To Present Data On Preclinical Results For Its HT-KIT For mRNA Frame-Shifting On Jun. 3 at 1 p.m. EDT

By Benzinga Newsdesk

Today, 2:24 AM

Shareholder Presentation Today to Further Highlight Results HT- KIT Reduces KIT expression and induces apoptosis of neoplastic human mast cells Inhibits tumor growth in humanized xenograft mast cell neoplasia

HOTH

2 minute read

FDA
News

United Therapeutics Announces First Patient Enrolled In Phase 3 TETON Study Of Tyvaso In Patients With Idiopathic Pulmonary Fibrosis

By Benzinga Newsdesk

Today, 2:24 AM

United Therapeutics Corporation (NASDAQ:UTHR) announced today that the first patient has enrolled in the phase 3 TETON study, which is expected to evaluate approximately 396 adult patients with idiopathic pulmonary

UTHR

1 minute read

Alpine Immune Sciences Says Presents ALPN-303 Data During 2021 EULAR Virtual Meeting

By Benzinga Newsdesk

Today, 2:24 AM

Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today made an oral presentation of

ALPN