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 ...
MyChesCo on MSN

China Clears IND for SEED Therapeutics’ First-in-Class Cancer Drug in Global Trial Push

SEED Therapeutics announced that China’s National Medical Products Administration has cleared the Investigational New Drug ...

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), ...
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, ...
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 ...
Business Wire

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 ...

RAHWAY, N.J.--(BUSINESS WIRE)--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 ...
Cure Today

FDA Approves Application for ABT-301 in Metastatic Colorectal Cancer

ABT-301, an HDAC1/2/3 inhibitor, enhances immune response and tumor microenvironment, potentially improving immune checkpoint inhibitor efficacy in metastatic colorectal cancer. The phase 1/2 trial ...
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 ...
The Caledonian-Record

ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a.

Garching / Munich, Germany, November 13, 2025 – (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) completed its filing review and ...
FierceBiotech

Stealth Bio submits third FDA application for rare disease candidate

After an FDA rejection in May, Stealth BioTherapeutics has resubmitted a new drug application for its investigational treatment designed to treat an ultra-rare genetic disease. This is the biotech’s ...
Healio

FDA accepts reproxalap new drug application for dry eye disease again

Please provide your email address to receive an email when new articles are posted on . This is the third new drug application for reproxalap that Aldeyra Therapeutics has submitted to the FDA. The ...