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NewsDermata Reports Positive Results from Tome Skincare Study
Dermata Therapeutics reports topline cosmetic study data for Tome Foundational Treatment, with 71% of participants showing improvement after one application.
Oryzon Secures Vafidemstat Patent Allowances in Four Markets

Zealand Pharma Partners With Generate on $1.2B AI Obesity Deal

Rasonque Gains CHMP Positive Opinion for Pancreatic Cancer

Lonza Completes Its CDMO Transformation After CHI Divestment

Latest news
11 storiesEvotec Appoints Dr. Joanna Holbrook as Chief Scientific Officer
Evotec appoints Dr. Joanna Holbrook as CSO effective November 2026, bringing AI, omics, and translational medicine expertise to its discovery platform.

Enodia Therapeutics Signs Pfizer Deal Worth Over $500 Million
Enodia Therapeutics and Pfizer sign a $500M deal; Pfizer takes full manufacturing and regulatory control post-collaboration.

Insmed Advances Four Phase 3 TPIP Studies
Insmed's PALM program runs four parallel Phase 3 TPIP studies across pulmonary diseases, targeting 2,000+ patients with a once-daily dry powder inhaler.

Par Health Recalls 22 Lots of Argatroban Injection
Par Health recalls 22 Argatroban Injection lots over multi-material particulate contamination, including stopper fragments and possible stainless steel.

FDA Updates Blood Donation Compliance Policy
FDA CBER finalizes compliance policy on blood donation suitability and Source Plasma quarantine holds under 21 CFR 630.30, 630.10(c)(2), and 640.69(f).

FDA Launches Rare Disease Framework Initiative
FDA's Rare Disease Framework Initiative proposes risk-based CMC review and pre-approval inspection changes, with a public meeting set for October 28, 2026.

Hepion Pharmaceuticals Acquires Gravitas Life Sciences
Hepion acquires Gravitas Life Sciences; FDA's written determination shifts GV104's 505(b)(2) critical path to manufacturing.

FibroBiologics Secures Australian Patent for Disc Regeneration
IP Australia issues Notice of Acceptance for FibroBiologics' fibroblast-PRP-nucleus pulposus disc regeneration method, weeks after a parallel European grant.

FDA Issues Blood Pressure and Pulse Donor Eligibility Policy
FDA's CBER issues compliance policy on donor blood pressure and pulse eligibility, with direct implications for Source Plasma collection and plasma-derived biologics supply chains.

FDA Accepts Atara Biotherapeutics’ Tabelecleucel BLA
FDA accepts Atara's tabelecleucel BLA resubmission as Class 2, setting a March 31, 2027 PDUFA date for the first potential U.S. allogeneic T-cell therapy approval.

FDA Expands ImmunityBio's Anktiva Approval
FDA expands Anktiva's indication to high-grade papillary BCG-unresponsive NMIBC via efficacy extrapolation from CIS trial data.

Worth your time this week

Roche Strikes Up to $1.16B Obesity Deal With Rona

Sanner Group COO Frank Bamberg Appointed to Lead Operations

CERVAVAC WHO Prequalification Secured by Serum Institute
