Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD

We believe that a partnership with Allucent, is a significant move forward in bringing our novel PTSD therapeutic to the clinic,” said Silo CEO Eric Weisblum. “With Allucent’s expertise, we believe ...
TipRanks on MSN

Nuvalent’s New Drug Application for zidesamtinib in NSCLC acepted by FDA

Nuvalent (NUVL) announced the FDA has accepted for filing its New Drug Application, or NDA, for zidesamtinib, an investigational ROS1-selective ...
CURE

FDA Grants Fast Track Status to New Gastric Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted fast track designation to DPTX3186, a first in class oral condensate ...

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food ...

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and ...
Nasdaq

Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.

Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after ...
Morningstar

Tivic Receives Two Investigational New Drug Applications for Entolimod™ for the Treatment of Acute Radiation Syndrome (ARS) and Advanced Cancers

INDs Transferred from Statera Biopharma Advance Entolimod for ARS Along Regulatory Pathway and Enable Pursuit of Clinical Trial Program in Neutropenia and Lymphocyte Exhaustion Tivic Health® Systems, ...

Evotec gets $5M milestone payment from Bristol Myers after FDA accepts new drug application

Evotec SE (EVO) on Wednesday said that it has received a $5 million milestone payment from Bristol Myers Squibb (BMY), ...

Merck's Investigational Two-Drug Regime Matches Gilead's Three-Drug Tablet For HIV Treatment

Merck's HIV pill met key efficacy and safety goals in Phase 3 trials, matching Biktarvy as the FDA reviews its application with a 2026 decision date.
IJR

FDA Quietly Approved New Abortion Drug After Promising Safety Investigation

The Food and Drug Administration (FDA) approved a new generic version of mifepristone on Tuesday. Weeks after confirming a review of the abortion pill was underway, the FDA approved the application of ...
Eagle-Tribune

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically ...

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ...
MarketWatch

Zymeworks Shares Climb After FDA Clears Investigational New Drug Application

Shares of Zymeworks were higher after the Food and Drug Administration cleared the company's investigational new drug application for its treatment for liver cancer. The stock rose 8.5%, to $14.46, in ...