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The submission sought accelerated approval and was part of the FDA Commissioner’s National Priority Voucher pilot programme. The CRL for bitopertin EPP affects the regulatory pathway and potential

The placement was led by existing investor BVF Partners and joined by entities such as Avidity Partners, OrbiMed, Trails Edge Capital Partners, TCGX, Vivo Capital and other institutional

The move is part of Ampersand’s strategy to establish a trans-Atlantic pharmaceutical development partnership through the Purna and MedPharm alliance. This partnership has the potential to become a

This approval provides a new option for long-term disease control in patients, with twice-yearly maintenance dosing after two initial loading doses. gMG is a rare, chronic, B-cell-mediated autoimmune

The agreement focuses on expanding Lymphir’s international access via country-specific managed access programmes, where permitted by local regulations. Under the terms, Uniphar will act as the exclusive distributor

The therapies are approved as second or third line treatment for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express programmed death-ligand 1 (PD-L1)

Under the agreement, Biocodex will hold an exclusive worldwide licence to develop and commercialise Batten-1, which has been developed by THX Pharma for juvenile Batten disease (CLN3). Additionally,

The companies plan to jointly develop at least two research and development (R&D) programmes using Insilico Medicine’s AI platform alongside CMS’ expertise in clinical development. Under the agreement,

The FDA accepted the gene therapy’s application under the accelerated approval pathway in May 2025. The CRL indicated that the FDA agreed in principle with the study protocol