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February 03, 2026 08:00 ET | Source: Byonyks

Byonyks X1: Revolutionizing Dialysis - Now FDA Cleared and Planning to start Patients in the U.S.

Byonyks’ FDA-cleared X1 advances home dialysis innovation, with Farrukh Usman leading a mission to transform patient-centric renal care globally.
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 30, 2026 07:00 ET | Source: Nutriband Inc.

Nutriband Inc. provides summary of Annual Shareholder Meeting Key Discussion Points

Annual shareholder meeting highlights
January 29, 2026 10:46 ET | Source: Quetzal Therapeutics

QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

CHICAGO, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Quetzal Therapeutics, a biopharmaceutical company focused on developing treatments for rare diseases, announced that the U.S. Food and Drug Administration...
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 28, 2026 12:00 ET | Source: Siren Biotechnology, Inc.

Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage

Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage
January 28, 2026 07:40 ET | Source: OKYO Pharma LTD

OKYO Pharma Announces Successful Type C Meeting with the FDA

LONDON and NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of...
January 27, 2026 07:00 ET | Source: Transpire Bio

Transpire Bio’s ANDA for Generic Trelegy® Ellipta® Accepted for Filing by the U.S. FDA

SUNRISE, Fla., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Transpire Bio, an integrated clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases,...
January 26, 2026 09:15 ET | Source: Longeveron

Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)

Longeveron granted FDA Type C meeting ahead of Q3 2026 data readout of pivotal clinical trial for stem cell therapy in hypoplastic left heart syndrome.
January 26, 2026 06:05 ET | Source: MannKind

MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy

MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin