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 ...
Nation

Defence PS faces arrest over Sh25.4m payout to 1982 coup victims

The High Court has ordered the Inspector-General of Police to execute a warrant of arrest against Defence Principal Secretary ...

Grace Therapeutics Announces Second Quarter 2026 Financial Results, Provides Business Update

FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) ...
The Hindu

NDA to set up defence corridor in Bihar, form commission to mitigate floods if voted to power: Shah

Union Home Minister Amit Shah on Monday (November 3, 2025) said a defence corridor will come up in Bihar and factories will be set up in each district if the NDA is voted to power. Bihar Assembly ...
NDTV

"NDA Will Win 160 Seats, Form Government With Two-Thirds Majority": Amit Shah Exclusive

Union Home Minister Amit Shah has said they are "fighting under Nitish Kumar's leadership" Amit Shah has credited Nitish Kumar's leadership for improved law and order in Bihar NDA is highlighting ...
Mena FN

Mahagathbandhan Facing Internal Divisions, NDA Will Form Govt Again In Bihar: Shahnawaz Hussain

(MENAFN- IANS) New Delhi, Nov 2 (IANS) As the countdown to the 2025 Bihar Assembly elections picks up pace, leaders of the ruling alliance have launched a full-throated campaign of confidence, ...
Asian News International

"Voters have decided to form NDA government with 2/3rd majority": Bihar BJP chief Dilip Jaiswal

Patna (Bihar) [India], October 24 (ANI): Ahead of Prime Minister Narendra Modi's visit to Bihar, state BJP president Dilip Jaiswal on Friday exuded confidence that the NDA will win the assembly ...
Asian News International

"NDA will form government with thumping majority in Bihar" says Rajasthan Deputy CM Diya Kumari

Jaipur, (Rajasthan) [India], October 21 (ANI): Rajasthan Deputy Chief Minister Diya Kumari on Tuesday expressed confidence in the NDA's success in the upcoming Bihar election. After participating in ...
KXAN

TAHO Pharma Announces Submission of New Drug Application (NDA) to the U.S. FDA for TAH3311 - The World's First Apixaban Oral Dissolving Film - Represents a Transformational ...

TAIPEI, Oct. 1, 2025 /PRNewswire/ -- TAHO Pharmaceuticals Ltd. ("TAHO Pharma") today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...
MarketWatch

(CNW) TAHO Pharma Announces Submission of New Drug Application (NDA) to the U.S. FDA for TAH3311 - The World's First Apixaban Oral Dissolving Film - Represents a ...

The MarketWatch News Department was not involved in the creation of this content. TAIPEI, Oct. 1, 2025 /CNW/ -- TAHO Pharmaceuticals Ltd. ("TAHO Pharma") today announced the submission of its New Drug ...
The New York Times

Why Canadiens are looking to Noah Dobson and Mike Matheson to form their top defence pair

BROSSARD, Que. — Training camp is a good time to experiment with different combinations to see what works and what doesn’t. However, Montreal Canadiens coach Martin St. Louis does not sound like ...
Morningstar

Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S.