FDA Archives - Page 158 of 220

4 minute read

BMF-219 Enters the Clinic For KRAS Solid Tumor; Biomea Fusion Announces FDA Clearance Of Investigational New Drug Application For Covalent Menin Inhibitor BMF-219 In KRAS Solid Tumors

October 14, 9:02 AM

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial

BMEA

1 minute read

FDA
News

Moleculin Provides Update On Second Multiple Ascending Dose (MAD) Cohort In Phase 1a Clinical Trial Of WP1122 In UK; Shares Move Lower

By Benzinga Newsdesk

October 14, 8:42 AM

Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors

MBRX

3 minute read

T2 Biosystems Highlights Multiple New Studies Demonstrating Improved Rapid Detection Across Several Patient Populations

By Benzinga Newsdesk

October 14, 8:39 AM

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the publication of three new, peer-reviewed studies that demonstrate

TTOO

5 minute read

Mirum Pharmaceuticals Announces CHMP Opinion For LIVMARL Oral Solution For Cholestatic Pruritus In Patients With Alagille Syndrome Two Months Of Age And Older

By Benzinga Newsdesk

October 14, 8:07 AM

- CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and clinically meaningful improvements in cholestatic pruritus and serum bile acids for patients with Alagille syndrome

MIRM

1 minute read

FDA
News

BridgeBio Pharma Presents 12-month Results from Phase 2 Study of BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i

By Benzinga Newsdesk

October 14, 7:33 AM

Novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total

BBIO

2 minute read

Regeneron Pharmaceuticals Announces Libtayo Receives Positive CHMP Opinion Recommending Approval To Treat Advanced Cervical Cancer

By Benzinga Newsdesk

October 14, 7:05 AM

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for

REGN

1 minute read

FDA
News

BeiGene Receives Positive CHMP Opinion For BRUKINSA (zanubrutinib) For Treatment Of Adults With CLL

By Benzinga Newsdesk

October 14, 6:30 AM

BeiGene (NASDAQ:BGNE, HKEX: 06160, SSE: 688235)))), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, today

BGNE

1 minute read

FDA
News

Reata Pharmaceuticals Announces FDA Does Not Plan To Hold Advisory Committee Meeting To Discuss The NDA For Omaveloxolone For Friedreich’s Ataxia

By Michael Horton

October 13, 4:38 PM

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, announced that the U.S. Food

RETA

2 minute read

XBiotech Announces First Patient Enrolled Into The French National Cancer Institute Sponsored Phase I/II/III Clinical Study For Natrunix Therapy For Colorectal Cancer

By Benzinga Newsdesk

October 13, 12:46 PM

XBiotech (NASDAQ:XBIT) announced today the enrollment of the first patient in a multicenter, randomized clinical study for Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer.

XBIT