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 ...

Vasa Therapeutics Granted FDA Fast Track Designation for VS-041, a Novel Investigational Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)

Vasa Therapeutics ("Vasa"), a private, clinical stage biotechnology company developing novel therapies for cardiovascular and ...

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), ...

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 ...
Pharmaceutical Technology on MSN

FDA unveils new pathway to usher bespoke therapies to market

The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...
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, ...
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 ...
MarketWatch

Hinge Bio Announces FDA Clearance of Investigational New Drug Application for HB2198, a Novel B cell-Depleting Agent, for Patients with Systemic Lupus Erythematosus and Lupus ...

The MarketWatch News Department was not involved in the creation of this content. BURLINGAME, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Hinge Bio, Inc., a privately-held biotechnology company engaged ...
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 ...
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 ...
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 ...