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At World Sleep 2025, Avadel Pharmaceuticals will present new data on LUMRYZ™ (sodium oxybate) for extended-release oral suspension

Avadel Pharmaceuticals plc a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16...

Nuvation Bio unveils new data on IBTROZI™ (taletrectinib) in advanced ROS1-positive non-small cell lung cancer

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced new and updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib) for...

In the IDeate-Lung01 Phase 2 trial, Ifinatamab Deruxtecan demonstrated clinically meaningful response rates in patients with extensive-stage small cell lung cancer

Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These data were...

Precision BioSciences announces a U.S. patent covering PBGENE-HBV for chronic hepatitis B and provides updates on the program's status

Precision BioSciences, Inc. a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, announced that it will be issued U.S. Patent No....

Experic appoints Jeffrey Shane as Chief Commercial Officer

Experic, a contract development and manufacturing organization (CDMO) and clinical trial supply services company serving the biopharmaceutical industry, today announced the appointment of Jeffrey Shane as its Chief Commercial Officer. Mr. Shane...

Mytos announces partnerships with StemSight, Rinri Therapeutics, and Novadip to drive next-generation cell therapy trials

Mytos, a biotechnology company automating cell manufacturing, announced new manufacturing collaborations with three innovative biotech companies - StemSight, Rinri Therapeutics, and Novadip. Each company intends to integrate Mytos’ iDEM automated...

Eisai submitted a rolling sBLA to the U.S. FDA for LEQEMBI® IQLIK™ as a subcutaneous starting dose to treat early Alzheimer’s, under Fast Track status

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...

Pharma Equity Groups datterselskab, Reponex Pharmaceuticals A/S, har fået godkendelse til at starte klinisk studie med RNX-011 mod livstruende peritonitis

Reponex Pharmaceuticals A/S (Reponex), et datterselskab af Pharma Equity Group A/S har i dag meddelt, at selskabet har modtaget myndighedsgodkendelse til at igangsætte et afgørende fase 2-studie med lægemiddelkandidaten RNX-011. Studiet skal...

CorrectSequence Therapeutics' CS-101 Achieves Promising Results in First Patient: High-Precision Base Editing Clinical Treatment for Sickle Cell Disease

CorrectSequence Therapeutics Co., Ltd. (Correctseq), a clinical-stage biotechnology company pioneering transformer Base Editing (tBE) technology for the treatment of severe diseases, today announced the successful treatment of the first sickle...

2025 Interim Results and Business Updates Announced by Innovent

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases,...

Gvoke VialDx™ (glucagon injection) Launched by American Regent

American Regent, Inc.® is pleased to announce the commercial launch and availability of Gvoke VialDx™ (glucagon injection). Gvoke VialDx (glucagon injection) is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic...

Innovent Biologics announces U.S. FDA IND approval for Phase 3 MarsLight-11 study of IBI363 in squamous NSCLC

Innovent Biologics, Inc. a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major...

Theravance Biopharma completes enrollment in Phase 3 CYPRESS study of Ampreloxetine for neurogenic orthostatic hypotension

Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...

VASTHERA Receives U.S. FDA Clearance to Begin Phase 1 Clinical Trial of Pulmonary Arterial Hypertension Drug Candidate, VTB-10

VASTHERA Co., Ltd. announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension...

GoodRx has announced a collaboration with Novo Nordisk to offer expanded access to Ozempic® and Wegovy® for $499 per month

GoodRx the leading platform for medication savings in the U.S., announced that via a collaboration with Novo Nordisk, all strengths of Ozempic® (semaglutide) and Wegovy® (semaglutide) pens are available to eligible self-paying patients for...

Spruce Biosciences Reports Long-Term Data Showing Efficacy and Safety of Tralesinidase Alfa in Sanfilippo Syndrome Type B

Spruce Biosciences, Inc. a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, announced results from a long-term data integration of...

Izalontamab Brengitecan Receives FDA Breakthrough Therapy Designation for Advanced EGFR-Mutated NSCLC

SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted. Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for...

Proving the strength of its drug-delivery platform, the Daewoong Therapeutics Microneedle Patch achieves best-in-class bioavailability

Daewoong Pharmaceutical (Co-CEOs Seong-Soo Park and Chang-Jae Lee) and Daewoong Therapeutics (CEO Bok-Ki Kang) announced that their proprietary semaglutide microneedle patch achieved more than 80%relative bioavailability compared to the injectable...

Abcentra LLC Commences Phase 2b 'FORTIFY' Trial with First Patient Dosed, Evaluating Orticumab for Cardiovascular Disease

Abcentra LLC, a clinical-stage biopharmaceutical company pioneering targeted therapies for cardiovascular inflammation, today announced the successful dosing of the first patient in its Phase 2b trial, FORTIFY, evaluating orticumab in patients...

Viatris announces the approval of the first generic iron sucrose injection in the U.S

Viatris Inc. a global healthcare company, announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric...