News about "New Drug Application "

HUTCHMED, AstraZeneca Submit US NDA for Orpathys-Tagrisso Combination

AstraZeneca submits a US FDA NDA for Orpathys plus Tagrisso in MET-driven NSCLC following EGFR-TKI progression, supported by positive Phase 3 SAFFRON PFS and OS results.

New Drug Application | 01/10/2026 | By News Bureau |  100

Gossamer Bio Submits First NDA for Seralutinib in PAH

Gossamer Bio has filed an NDA for seralutinib, supported by Phase 3 PROSERA and Phase 2 TORREY study data.

New Drug Application | 25/09/2026 | By News Bureau

Xenon Submits NDA for Azetukalner in Focal Seizures to US FDA

Xenon Pharmaceuticals has submitted an NDA to the US FDA for azetukalner in focal seizures, supported by data from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials.

New Drug Application | 21/09/2026 | By News Bureau |  112

Laekna's LAE002 Breast Cancer Drug Application Accepted by China's NMPA

Laekna has advanced LAE002 toward potential commercialisation in China after the NMPA accepted its NDA for afuresertib in patients with advanced HR+/HER2- breast cancer.

New Drug Application | 12/08/2026 | By News Bureau |  153

Reckitt Secures FDA Approval for First OTC Cold and Flu Innovation in 14 Years

Reckitt has received U.S. FDA approval for Mucinex 12HR Cold and Fever Multi-Symptom, marking the first over-the-counter cold and flu innovation approved in 14 years. The product combines three active ingredients in a first-of-its-kind bilayer tablet designed to deliver extended relief for multiple cold and flu symptoms.

New Drug Application | 06/08/2026 | By News Bureau |  161

US FDA Approves Lupin's Generic Diazepam Injection in Prefilled Syringe Format

Lupin has secured US FDA approval for its generic diazepam injection USP in a single-dose prefilled syringe format. The bioequivalent version of Roche's Valium injection expands the company's US injectable portfolio and addresses a market valued at nearly USD 78 million annually.

New Drug Application | 04/08/2026 | By News Bureau |  101

Gland Pharma Receives US FDA Approval for Generic Sugammadex Injection

Gland Pharma has secured US FDA approval for its generic Sugammadex Injection and launched the product in the US, strengthening its injectable portfolio in a market valued at approximately USD 1.6 billion annually.

New Drug Application | 29/07/2026 | By News Bureau |  132

US FDA Issues Complete Response Letter for Ascelia Pharma's Orviglance NDA

Ascelia Pharma has received a Complete Response Letter from the US FDA for its New Drug Application for Orviglance, prompting the company to seek further regulatory discussions while reaffirming its commitment to advancing the rare oncology therapy.

New Drug Application | 06/07/2026 | By News Bureau |  460

US FDA Accepts NDA for Genentech's Giredestrant in ER-Positive Early-Stage Breast Cancer

The US FDA has accepted Genentech’s New Drug Application (NDA) for giredestrant, an investigational oral SERD for ER-positive early-stage breast cancer. Supported by positive phase 3 trial results, giredestrant is the first and only oral SERD to demonstrate efficacy in the curative setting.

New Drug Application | 03/06/2026 | By News Bureau |  116

Lynk Pharmaceuticals Secures NMPA NDA Acceptance for Zemprocitinib

Lynk Pharmaceuticals announces NMPA acceptance of Zemprocitinib NDA, backed by positive results from a phase-III randomised, double-blind, placebo-controlled clinical trial in China.

New Drug Application | 11/04/2026 | By News Bureau |  155