Capricor Therapeutics Updates on Deramiocel BLA for Duchenne Muscular Dystrophy
Capricor Therapeutics has announced progress on its Biologics License Application for Deramiocel, its lead cell therapy for DMD-associated cardiomyopathy, with the FDA maintaining Priority Review and no Advisory Committee meeting planned ahead of the August 31, 2025 PDUFA date.
Global Pharma | 26/06/2025 | By Manvi | 189
Lupin Secures US FDA Approval for Prucalopride Tablets
Lupin has received US FDA approval for its generic Prucalopride Tablets, 1 mg and 2 mg, for the treatment of chronic idiopathic constipation (CIC) in adults. This product will be manufactured at Lupin's Goa facility in India.
Global Pharma | 25/06/2025 | By Manvi | 188
Nitinotes Receives FDA Approval to Initiate Pivotal Trial for EndoZip Suturing System
Nitinotes, developer of the EndoZip™ System announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).
Global Pharma | 25/06/2025 | By Manvi | 170
Illumina to Acquire SomaLogic for USD 350 Million to Accelerate its Proteomics Business
Illumina has announced a definitive agreement to acquire proteomics firm SomaLogic and other assets from Standard BioTools for up to USD 425 million, strengthening its multiomics strategy and expanding its footprint in the fast-growing proteomics market.
Global Pharma | 24/06/2025 | By Manvi | 147
Cerapedics Receives FDA Approval for PearlMatrix Bone Graft
Cerapedics Inc. announced the U.S. Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level transforminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD).
Global Pharma | 24/06/2025 | By Manvi | 884
Glenmark Launches TEVIMBRA in India for Lung and Esophageal Cancer Treatment
Glenmark Pharmaceuticals has launched TEVIMBRA (tislelizumab) in India, marking its entry into immuno-oncology with a globally approved PD-1 inhibitor for advanced lung and esophageal cancers.
Global Pharma | 24/06/2025 | By Manvi | 205
PharmaJet, Immuno Cure Partner for Clinical Development of a Needle-free HIV Therapeutic DNA Vaccine
PharmaJet has partnered with Immuno Cure to provide its needle-free Tropis ID system for delivering ICVAX, a novel therapeutic HIV-1 DNA vaccine, in a human clinical trial—aiming to enhance vaccine performance and patient experience while advancing toward a functional HIV cure.
Global Pharma | 23/06/2025 | By Manvi | 125
IONETIX and AlfaRim Announce Strategic Collaboration on Cyclotron-Produced Actinium-225
IONETIX and AlfaRim announced a strategic collaboration to commercialize cyclotron-produced actinium-225, a key isotope enabling next-generation targeted alpha therapies (TATs).
Global Pharma | 23/06/2025 | By Manvi | 255
Under the agreement, TerraPower Isotopes would supply Ratio with quantities of non-cGMP Ac-225 for use to incorporate into or use in the development of Ratio's radiopharmaceuticals.
Global Pharma | 21/06/2025 | By Manvi | 166
Catalyst MedTech Named Exclusive US Distributor of CareMiBrain
Catalyst MedTech has announced it will serve as the exclusive US distributor of CareMiBrain™, an ultra-high resolution dedicated brain PET system developed by MindView / OncoVision.
Global Pharma | 21/06/2025 | By Manvi | 101
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