MarketScreener

U.S. FDA Accepts Bayer’s Supplemental New Drug Application for KERENDIA® (finerenone) to Treat Adults with Chronic Kidney Disease (CKD) Without Diabetes

Bayer announced today that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for KERENDIA ® (finerenone), which is being investigated for the ...

FDA ACCEPTS NEW DRUG APPLICATION FOR CELECOR'S INVESTIGATIONAL HEART-ATTACK DRUG

The U.S. Food and Drug Administration has accepted CeleCor Therapeutics' New Drug Application (NDA) for zalunfiban (DisaggproTM) and assigned a target action date of June 18, 2027 under the ...
TMCnet

Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body

Ameluz ® PDT is currently FDA approved for AKs on the face and scalp and, since September 2026, for superficial basal cell carcinoma (sBCC). If approved, the new indication would make Ameluz ® with ...

New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Tim…

In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival ...

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification ...
Targeted Oncology

New Drug Application Filed for Savolitinib/Osimertinib in MET+ NSCLC

The application is supported by the phase 3 SAFFRON trial, in which savolitinib plus osimertinib improved progression-free ...

Crescent Biopharma Receives FDA Clearance for Investigational New Drug Application

Crescent Biopharma said the Food and Drug Administration cleared its investigational new drug application for CR-002 to treat advanced solid tumors. Chief Medical Officer Ellie Im on Monday said the ...
JD Supra

FDA Opens Applications for New Pilot to Shorten Drug Approval Times: What Sponsors Need to Know

Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the “Program”), an initiative ...

Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate

Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor ...
MarketScreener

Biofrontera Inc. Submits Supplemental New Drug Application to Fda to Expand Ameluz Red Light Pdt to Actinic Keratoses on the Full Body

Biofrontera Inc. announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for Ameluz® (aminolevulinic acid ...