Understanding ANDA: Process for Approving Generic Drugs by the FDA

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

Novo Nordisk Files FDA Application For Weekly Combination Obesity Shot

Novo Nordisk filed an FDA application for weekly CagriSema after trials showed up to 22.7% weight loss versus placebo.
Business Wire

Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...
The Manila Times

Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic

REX-8756 is a potent and selective oral STAT6 inhibitor that has shown complete 100% pathway inhibition and potent efficacy in preclinical models of asthma, acute lung inflammation and ...
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 ...
Healio

FDA accepts new drug application for sublingual epinephrine film

Please provide your email address to receive an email when new articles are posted on . Aquestive Therapeutics’ Anaphylm sublingual film is about the size of a postage stamp. Anaphylm’s time to ...
Cure Today

FDA Accepts New Drug Application for Relacorilant in Ovarian Cancer

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...
ALS News Today

Survival benefit seen for patients with ALS drug CNM-Au8: New data

Clene is planning to submit an application to the FDA in early 2026 requesting the accelerated approval of CNM-Au8 for ALS.
Medscape

First New PTSD Drug in Two Decades On the Horizon?

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in ...

Alphamab Oncology Announces IND Application for Innovative PD-L1/ VEGFR2 Bispecific ADC JSKN027 was Officially Accepted by CDE

Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN027, an ...
FiercePharma

FDA avoids the worst amid government shutdown, but new applications put on hold

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...
Seeking Alpha

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, ...