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Bayer Receives U.S. FDA Breakthrough Therapy Designation for ...


Bayer Gets U.S. FDA Breakthrough Therapy Designation for Lung ...

Bayer received a breakthrough therapy designation from the U.S. Food and Drug Administration for its BAY 2927088 lung cancer treatment. The ...

Sanofi, Regeneron: Cemiplimab Receives FDA Breakthrough ...

Sanofi and Regeneron Announce That Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous ...

Bayer Granted FDA Breakthrough Therapy Designation for Non ...

BAY 2927088 is an oral, reversible small molecule tyrosine kinase inhibitor being analyzed for the treatment of unresectable or metastatic non- ...

FDA Grants Dupixent® (dupilumab) Breakthrough Therapy ...

(NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent® ...

Bayer pharma commercial boss talks restructuring, oncology goal

The team for Bayer's prostate cancer drug Nubeqa is one of the front-runners groups. Bayer has pegged the androgen receptor inhibitor to reach ...

FDA approves an oncology drug that targets a key genetic driver of ...

The US Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers ...

Arrivent's Furmonertinib Receives FDA Breakthrough Therapy ...

ArriVent Biopharma, Inc. announced that the FDA has granted breakthrough therapy designation to furmonertinib for the treatment of patients ...

Bayer-Receives-US-FDA-Breakthrough-Therapy ... - Larvol Delta

BAY 2927088 - Bayer, Broad Institute. midazolam hydrochloride - Generic mfg. http://clinicaltrials.gov/ct2/show/NCT06360211. May 31, 2024. SHARE THIS. Print ...

U.S. FDA grants Breakthrough Therapy designation for MASH

Boehringer Ingelheim receives U.S. FDA Breakthrough Therapy designation for people living with MASH and liver fibrosis.

FDA approves larotrectinib for solid tumors with NTRK gene fusions

This is the second tissue-agnostic FDA approval for the treatment of cancer. Approval was based on data from three multicenter, open-label, ...

Sagimet Biosciences Reports Third Quarter 2024 Financial Results ...

On October 1, Sagimet announced that the FDA granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH ...

BridgeBio Pharma Reports Third Quarter 2024 Financial Results ...

The FDA granted Breakthrough Therapy Designation to infigratinib for demonstrating substantial improvement in efficacy over available ...

Novartis receives FDA Breakthrough Therapy designation for ...

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177 Lu-PSMA-617.

BridgeBio Pharma Reports Third Quarter 2024 Financial

Upon FDA approval of acoramidis, it is our intent to honor the courage of our U.S. clinical trial patients by providing them acoramidis free for ...

U.S. Food and Drug Administration (FDA) accepts New Drug ...

Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for the ...

Rx Rundown: Roche, Metsera, Intercept Pharmaceuticals and more

Autolus Therapeutics said it received approval from the FDA for its treatment of acute lymphoblastic leukemia. West Virginia-based Berkeley Club ...

Alteogen Enters License Deal With Daiichi Sankyo For ALT-B4 In ...

Alteogen Enters License Deal With Daiichi Sankyo For ALT-B4 In Subcutaneous ENHERTU Development · Daiichi Says Enhertu Gets Priority Review In US ...

AskBio Receives FDA Rare Pediatric Disease and Orphan-Drug ...

AskBio Receives FDA Rare Pediatric Disease and Orphan-Drug Designations for AB-1003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2I/ ...

Pharma Stock Roundup: AZN, BAYRY's Earnings, ABBV's Pipeline ...

The FDA granted Breakthrough Therapy Designation to J&J's key pipeline candidate, nipocalimab, for treating moderate-to-severe Sjögren's disease ...

Bio-Techne hematology devices receive IVDR certification

Sensorion receives clinical trial approval for congenital deafness gene therapy ... Delivered right to your inbox, LabPulse's newsletters keep you ...