BioSpace News Archive

Pharm Country

Tiziana Life Sciences Announces Chief Medical Officer Invited to Give Presentation on Intranasal Foralumab on May 17

Tiziana Life Sciences Ltd. today announced that its Chief Medical Officer is presenting at the Hanson Wade Novel Nasal Formulation and Delivery Summit on May 17 in San Diego.

May 17, 2023
·
2 min read
Pharm Country

Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma

Elevar Therapeutics, Inc. today announced it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor.

May 17, 2023
·
6 min read
BioMidwest

EXACT SCIENCES AWARDS GRANTS TO 18 ORGANIZATIONS FOCUSED ON INCREASING COLORECTAL CANCER SCREENINGS

Exact Sciences announced today that it awarded $1.1 million to 18 organizations through its Funding Opportunities for CRC Screening Uptake Strategies (FOCUS) Program.

May 17, 2023
·
11 min read
Business

BioLineRx to Report First Quarter 2023 Results on May 24, 2023

BioLineRx Ltd. announced today that it will release its unaudited financial results for the quarter ended March 31, 2023 on Wednesday, May 24, 2023, before the U.S. markets open.

May 17, 2023
·
2 min read
Drug Development

PTC Therapeutics Announces APHENITY Trial Achieved Primary Endpoint with Sepiapterin in PKU Patients

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the primary endpoint was achieved in the APHENITY, Phase 3 registration-directed clinical trial of sepiapterin in adult and pediatric patients with phenylketonuria (PKU).

May 17, 2023
·
7 min read
Drug Development

Indapta Therapeutics Announces U.S. FDA Clearance of IND for IDP-023, an Allogeneic Natural Killer (NK) Cell Therapy for Cancer

Indapta Therapeutics, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application to commence its first-in-human phase 1 trial in patients with multiple myeloma and lymphoma anticipated to begin in the second half of 2023.

May 17, 2023
·
2 min read
Business

Closed Loop Medicine and Pharmanovia enter a co-development partnership for precision medicine combination therapeutics

Closed Loop Medicine Ltd and Pharmanovia today announced that they have entered a global co-development partnership.

May 17, 2023
·
3 min read
Drug Development

TAGRISSO® (osimertinib) plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial

Positive high-level results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO ®.

May 17, 2023
·
12 min read
Genetown

Ardelyx Announces FDA Acceptance and Six-Month Review for Resubmission of its New Drug Application of XPHOZAH® (tenapanor)User Fee Goal Date: October 17, 2023

Ardelyx, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of a New Drug Application (NDA) for XPHOZAH ® (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.

May 17, 2023
·
4 min read
Business

BrainsWay Reports First Quarter 2023 Financial Results and Operational Highlights

BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported first quarter 2023 financial results and provided an operational update.

May 17, 2023
·
10 min read