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News about "New Drug Application "
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 | 224
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 | 101
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 | 617
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 | 148
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 | 160
Daiichi Sankyo Submits sNDA in Japan for Datroway in First-Line Metastatic TNBC
Daiichi Sankyo files supplemental application in Japan for Datroway as a first-line treatment for metastatic triple negative breast cancer based on phase III trial data.
New Drug Application | 13/02/2026 | By News Bureau | 200
Takeda's Oveporexton NDA Accepted by US FDA with Priority Review for Narcolepsy Type 1
FDA grants Priority Review to Takeda’s investigational orexin receptor agonist oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA decision expected in Q3 this year.
New Drug Application | 11/02/2026 | By News Bureau | 177
HUTCHMED Gets Priority Review in China for Fanregratinib NDA
HUTCHMED’s NDA for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted in China with priority review status, supported by data from a phase II registration trial addressing a high-unmet-need liver cancer indication.
New Drug Application | 02/01/2026 | By News Bureau | 121
Cogent Biosciences Submits NDA for Bezuclastinib in Non Advanced Systemic Mastocytosis
Cogent Biosciences has submitted a New Drug Application to the US FDA for bezuclastinib in non-advanced systemic mastocytosis, supported by positive results from the SUMMIT pivotal trial and following its Breakthrough Therapy Designation for patients with smouldering systemic mastocytosis and previously treated NonAdvSM.
New Drug Application | 31/12/2025 | By News Bureau | 215
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