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®)...
Sai Life Sciences Limited an innovator-focused Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the completion of Phase II of its new Production Block (PB-11) at the company’s flagship API manufacturing...
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...
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...
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 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...
Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...
SkinCeuticals, the #1 Medical Aesthetic Skincare Brand Worldwide*, announces the launch of A.G.E. Interrupter Ultra Serum, the latest science-backed product in its A.G.E. line. Sagging skin is a top concern driving patients to dermatologists, and...
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...
Dash Bio, a preclinical and clinical bioanalysis company reinventing the speed and scalability of drug development, announced it has raised an additional $11 million in funding, bringing its total raised to $17.5 million. The new financing was led...
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") announced LEQSELVI™ (deuruxolitinib) 8 mg tablets is now available...
Fresenius announced that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States. These denosumab biosimilars are approved by the FDA for all...
Neurocrine Biosciences, Inc. announced new patient-reported post-hoc data from the KINECT®-HD study highlighting significant reductions in both cognitive and motor-related burdens among adults treated for Huntington's disease chorea with...
Shed, a modern wellness company focused on helping individuals feel and function their best, announces the launch of several new products designed to provide affordable, weight management support options for individuals at every stage of their...
Kashiv BioSciences, LLC announced positive topline results from its confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab). The randomized, double-blind, multicenter study...
Regeneron Pharmaceuticals, Inc. and Sanofi today presented positive results from the EVEREST Phase 4 trial in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In the trial, Dupixent® (dupilumab)...
Genmab A/S announced new results from the Phase 1b/2 EPCORE® NHL-2 trial Arm 10 (NCT04663347), evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab, ifosfamide, carboplatin, and...
Avanzanite Bioscience B.V. (“Avanzanite”), a fast-growing commercial-stage specialty pharmaceutical company dedicated to bringing rare disease medicines to patients across Europe, announced an exclusive agreement with Agios Pharmaceuticals Inc. A...
Emulate, Inc., the world leader in Organ-on-a-Chip technology, today announced the commercial launch of the AVA™ Emulation System, a self-contained instrument that cultures, incubates, and images up to 96 independent Organ-Chip samples in a single...
On the occasion of National Bioproduction and Biomedicines Day (JNBB), which enjoys the high patronage of the President of the French Republic, HTL Biotechnology confirms its position as a globalleader in the development and production of...
