Johnson & Johnson announced FDA approval of a label expansion for Akeega (niraparib and abiraterone acetate dual-action tablet; niraparib and abiraterone acetate) plus prednisone (niraparib and abiraterone acetate plus prednisone) for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC) on December 12th, 2025. Patients are eligible for the therapy following results from an FDA-approved test for genetic […]
Post Type Archives: News
FDA Approves Pair of Gonorrhea Treatments
FDA approved two unrelated treatments for Uncomplicated Urogenital Gonorrhea (gonorrhea) back-to-back from December 11th to 12th, 2025. FDA granted GSK’s Bluejapa (gepotidacin) a label expansion for the indication on the 11th, while Innoviva’s Nuzolvence (zoliflodacin) received the nod on the 12th. Both treatments are indicated for patients aged 12 years and older who have few […]
PolyPeptide and Lupin Manufacturing Solutions Form Strategic Alliance to Meet Growing Demand for Peptide Supply in Metabolic Therapies
PolyPeptide Group AG, a global CDMO for peptide-based APIs, and Lupin Manufacturing Solutions Limited (LMS) have formed a strategic alliance to enhance supply chain resilience, improve operational efficiency, and support the long-term growth of both organizations. Through this alliance, PolyPeptide will broaden its sourcing options for key materials, establishing a more robust and flexible supply […]
Non-Profit Earns FDA Approval for Wiskott-Aldrich Syndrome Gene Therapy
Relation, a biopharmaceutical company developing medicines across immunology, metabolic, and bone diseases, announced a multi-program, strategic collaboration with Novartis on December 9th, 2025. The partnership, valued at up to approximately $1.75 billion, aims to discover and advance novel targets for atopic diseases. According to a company press release, Novartis will pay Relation $55 million upfront […]
Zealand Pharma and OTR Therapeutics Announce Metabolic Partnership Worth Up to $2.5 Billion
Zealand Pharma, a biotechnology company focused on advancing medicines for obesity and metabolic health, announced a strategic collaboration with OTR Therapeutics, a biotechnology company advancing therapies for patient populations with high unmet medical needs, on December 11th, 2025. The multi-program strategic collaboration and license agreement, worth up to approximately $2.5 billion, will see the companies […]
FDA Grants Label Expansion to Amgen’s Uplinza
Amgen announced FDA approval of a label expansion for Uplinza (inebilizumab-cdon) to include treatment of generalized myasthenia Gravis (gMG), a B-cell mediated autoimmune disorder, on December 11th, 2025. Adult patients who are anti-acetylcholine receptor (AChr) and anti-muscle specific tyrosine kinase (MuSK) antibody positive are eligible for the treatment. According to a company press release, gMG […]
Neupulse launches first-of-its-kind wearable with the support of Ensera Design to help people living with Tourette Syndrome
Neurotechnology company Neupulse has announced a first-of-its-kind wearable device proven to dramatically reduce the frequency and urge of tics in people living with Tourette Syndrome, marking a major milestone in the development of drug-free, non-invasive therapy for this condition. Developed with the design and engineering support of Ensera Design, a global healthcare innovation consultancy, the […]
Bora Pharmaceuticals and Corealis Pharma Forge Strategic Alliance to Deliver Seamless, End-to-End Oral Solid Dose Development
Bora Pharmaceuticals Co., Ltd. , a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing. The collaboration will simplify the drug development process and provide a more scalable pathway to […]
AsymBio Commences Commercial Operations at Fengxian Base, Strengthening Global Biopharmaceutical CDMO Capabilities
AsymBio, a technology-driven global Contract Development and Manufacturing Organization (CDMO) and a subsidiary of Asymchem Group, announced the official start of commercial production at its Shanghai Fengxian Commercial Manufacturing Base. This milestone expands AsymBio’s integrated, end-to-end biologics CDMO services and reinforces its commitment to accelerating the commercialization of innovative therapies worldwide Building on the success […]
Pillar Biosciences and AstraZeneca Expand Liquid Biopsy Collaboration
Pillar Biosciences, a provider of next-generation sequencing (NGS) technology, announced an expansion of its existing laboratory access program with AstraZeneca on December 8th, 2025. The collaboration, which intends to provide access to NGS-based kitted liquid biopsy tumor profiling, will now include China. Additionally, according to a company press release, AstraZeneca and Pillar will collaborate with […]