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January 30, 2026 10:59 ET | Source: Elevar Therapeutics

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular Carcinoma

FORT LEE, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
January 28, 2026 17:04 ET | Source: Elevar Therapeutics

Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib as Second-Line Treatment Option for Cholangiocarcinoma

FORT LEE, N.J., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
January 06, 2026 06:30 ET | Source: Biosplice Therapeutics, Inc.

Biosplice Announces the Submission of its New Drug Application (NDA) to the FDA for Lorecivivint (LOR) to Treat Knee Osteoarthritis

Biosplice announces submission of new drug application to US FDA for treatment of knee osteoarthritis
October 23, 2025 08:45 ET | Source: Biofrontera Inc.

Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG

Biofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG.New earnout structure reduces payment rate...
October 21, 2025 09:00 ET | Source: Dewpoint Therapeutics

Dewpoint Therapeutics Announces an Open IND for First-in-Class Condensate Modulator DPTX3186 for Wnt-Driven Cancers

Dewpoint Therapeutics today announced the opening of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for DPTX3186.
October 02, 2025 08:00 ET | Source: PharmaTher Holdings Ltd.

PharmaTher Provides Corporate Update on Ketamine Development and Commercial Strategy

TORONTO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the...
August 19, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19,...
August 06, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
July 15, 2025 07:01 ET | Source: Sixty Degrees Pharmaceuticals

60 Degrees Pharmaceuticals Defines Potential Human Babesiosis Market Size for ARAKODA® (tafenoquine): Annual Max TAM, Sales of $245 Million; Cumulative through Patent Expiration, $1.1 Billion

60 Degrees sets human babesiosis TAM for ARAKODA at $245M annually, $1.1B total through 2035; NDA planned for 2026 pending trial data.
July 09, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Appoints Nilay Patel as Chief Legal Officer to Support Growth ahead of New Drug Application

KANSAS CITY, Kan., July 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...