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News about "New Drug Application "
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 | 117
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 | 111
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
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 | 100
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 | 397
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
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 | 131
Japan's MHLW accepts GSK's Bepirovisen for Review to Treat Chronic Hepatitis B
Japan’s health ministry has accepted GSK’s new drug application for investigational antisense therapy bepirovirsen, after Phase III trials showed significantly higher functional cure rates in chronic hepatitis B patients.
New Drug Application | 27/02/2026 | By News Bureau | 714
FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in Rare Blood Disorder
US regulator seeks Phase III APOLLO trial results before approving bitopertin for erythropoietic protoporphyria, pushing potential decision until mid-2027.
New Drug Application | 19/02/2026 | By News Bureau | 183
Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.
New Drug Application | 19/02/2026 | By News Bureau | 210
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