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Marius Pharmaceuticals and Hims & Hers™ collaborate to expand access to KYZATREX® (testosterone undecanoate) CIII capsules, the first FDA-approved oral testosterone therapy available on the Hims & Hers platform

Marius Pharmaceuticals, Inc. announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone...

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...

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...

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...

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...

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...

ISPE Singapore Conference & Exhibition 2025

The ISPE Singapore Affiliate Conference & Exhibition is one of the largest and most respected pharmaceutical manufacturing shows in Singapore for pharmaceutical and biomanufacturing professionals. The ISPE Singapore Affiliate Conference &...

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...

13th World Conference on Pharmaceutical Science and Drug Manufacturing (WCPD) 2025

13th World Conference on Pharmaceutical Science and Drug Manufacturing (WCPD) 2025 hosted by IFERP Life Sciences will offer a diverse range of topics, from drug discovery and development to clinical trials, applications and healthcare delivery....

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...

To advance gene therapy development and manufacturing, ProBio has launched GMP AAV manufacturing services at its Hopewell facility

ProBio, a leading contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, announced the launch of its cGMP Adeno-Associated Virus (AAV) manufacturing services at its 128,000 sq. ft. state-of-the-art...

Jazz Pharmaceuticals announces the U.S. FDA approval of Modeyso™ (dordaviprone) as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...

MediPharm Labs launches a new nighttime inhaler, expanding its leading CBN oil portfolio

MediPharm Labs Corp. a pharmaceutical company specializing in precision-based cannabinoids, is pleased to announce it has launched the new Shake & Puff CBN THC Nighttime Inhaler in Canada. This innovative product expands MediPharm’s leading CBN...

FDA approves Apellis' EMPAVELI® (pegcetacoplan) as the first treatment for patients aged 12 and older with C3G and primary IC-MPGN

Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis...

Haleon’s Otrivin® Brand Now Features Aptar’s First Nasal Pump Made with 52% Bio-based Material

Aptar Pharma, a global leader in drug delivery and active material science solutions and services, is proud to announce that its Freepod® nasal spray pump - one of the delivery systems for Haleon's Otrivin® brand - is now made with mass balance...

BD Announces the First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs

BD (Becton, Dickinson and Company) a leading global medical technology company, announces the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. The...