Tanabe Eyes US NDA For Dersimelagon Following Positive Phase III Results In Rare Derma Disorders
Tanabe plans US NDA for first oral option for rare skin disorders EPP and XLP, as it looks to fill gap from Radicava divestment and overcome regulatory challenges for some other late-stage candidates.
Scrip - April 2, 2026

Industry Underprepared for QMSR Launch, Survey Finds
A new survey from Grand Avenue Software found 54% of life sciences firms were no more than “moderately” prepared for the FDA’s new Quality Management System Regulation at its February roll-out. Staffing and financial limitations, regulatory complexity, and lack of collaboration were common concerns.
Medtech Insight - April 1, 2026

US FDA Should Show Its Work on AdComm Conflict of Interest Decisions, GAO Says
The US Government Accountability Office urged the FDA to publish long?required guidance explaining how it evaluates advisory committee member conflicts of interest, spotlighting a transparency gap that has persisted despite a congressional mandate.
Medtech Insight - April 1, 2026

MedTech Europe Calls For Coordinated Wound Care Policy
A new report from the Wound Care Sector Working Group sounds the alarm: chronic wound care is rapidly becoming a growing burden. The EU must act now to make care coordination, reimbursement and innovation strategic priorities.
Medtech Insight - April 1, 2026

CIR Needs Phthalates Concentration Information
If and when CIR receives concentration of use data, it can calculate margins of exposure, which will help its expert panel assess the ingredients in light of potential endocrine disruption concerns for dibutyl and dimethyl.
HBW Insight - April 2, 2026

Celltrion Streamlines Keytruda Biosimilar Trial Amid FDA Shift
Celltrion has amended its CT-P51 pembrolizumab Phase III trial as it moves to capitalize on evolving FDA biosimilar guidance, aiming to cut development costs and timelines while aligning with an emerging industry shift toward streamlined clinical requirements.
Generics Bulletin - April 1, 2026

Regulatory Recap: ‘Predictability Is Essential’ For Pharma As Europe-Wide PFAS Ban Moves Forward
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - April 1, 2026

Teva’s Prolia Biosimilar Approved By US FDA As Xolair Rival Filings Accepted In EU And US
Teva marked a three-milestone celebration in its biosimilar portfolio – an approval and dual filing acceptance – as the firm advances its Pivot to Growth strategy.
Generics Bulletin - April 1, 2026

What’s Next? Five Things To Look Out For In April
Generics Bulletin previews the most noteworthy and anticipated events for April 2026.
Generics Bulletin - April 1, 2026

Insilico’s CEO On AI, Drug Novelty And Beating China Biotech At R&D
CEO Alex Zhavoronkov talks about the firm’s progress in AI-driven R&D, hitting the right level of drug novelty, partnering with Eli Lilly and its goal of outperforming China’s biopharma engine.
In Vivo - April 1, 2026

BioBytes: AI-Related Deals In Q1 ‘26
AI-led biotech dealmaking in Q1FY26 accelerated across financings, IPOs and pharma alliances, signalling a shift from experimentation to scaled deployment.
In Vivo - April 1, 2026

Factors Driving Change For Medtechs And Biotechs – A Legal View
Goodwin partner Sophie McGrath outlined six key themes for medical device and biotech companies driving innovation or seeking investment in markets now emerging from a relatively subdued fundraising environment in the post-pandemic period.
In Vivo - April 1, 2026