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Aug 15, 2026
Data center buildout faces growing legal and regulatory hurdles: environmental citizen suits, EU cloud rules that could exclude U.S. Big Tech from strategic tenders, and national security scrutiny of sovereign wealth fund investments. Local moratoria are spreading, and new EU rules would fast-track data centers while imposing non-price criteria.
Aug 10, 2026
Alnylam reported Q4 2025 adjusted EPS of $1.25, beating estimates, while revenue of $1.10 billion missed consensus despite 85% growth. Amvuttra sales surged 189% to $826.6 million. The stock fell 4.1% after the mixed results.
Aug 02, 2026
Moderna posted Q2 2026 revenue of $145 million and a GAAP net loss of $0.8 billion, while improving its 2026 spending outlook. Its norovirus candidate missed Phase 3 interim criteria, and mFLUSIVA faces an August 5 PDUFA decision.
Jul 01, 2026
PureTech Health's IPF drug deupirfenidone received orphan drug designation from the FDA and European Commission. The designation provides market exclusivity and financial incentives. A phase 3 trial is expected to begin in the first half of 2026.
Aug 09, 2026
Novartis marks 30 years since its 1996 merger, citing advances in targeted therapy, cell therapy, gene therapy, and malaria. It also named a Levant Country President and won two clinical research awards in Saudi Arabia.
Aug 06, 2026
Insmed reported Q2 2026 revenues of $425.5M, with BRINSUPRI at $309.2M. It raised 2026 BRINSUPRI guidance to $1.25B-$1.40B and lifted peak revenue estimates for its lead programs to over $14B.
Aug 07, 2026
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
Jul 22, 2026
FDA granted traditional approval to Novartis' Fabhalta (iptacopan) for IgA nephropathy. Phase 3 APPLAUSE-IgAN data showed eGFR decline slowed by 48% versus placebo over two years.
Aug 07, 2026
BioMarin reported Q2 2026 revenues of $990 million, up 20% Y/Y, and raised guidance. It filed an sNDA for VOXZOGO in hypochondroplasia and advanced BMN 333, BMN 820, and BMN 351.
Aug 08, 2026
Lupin reported record Q3 FY2026 revenue of INR 7,168 crores and a 31.1% EBITDA margin, while preparing to launch a generic semaglutide and shifting focus to innovation. The company also secured US FDA approval for Pegfilgrastim and EU approval for ranibizumab biosimilar.
Jul 24, 2026
The European Medicines Agency is enforcing clinical trial transparency and has launched a new vaccine information initiative, while a coalition of health professionals warns of suboptimal vaccination coverage across Europe. An analysis also shows that only a portion of EMA-approved medicines are available to NHS patients in England after additional assessments.
Jul 27, 2026
Novartis beat second-quarter profit expectations as Kisqali, Kesimpta and Leqvio offset a 50% plunge in Entresto sales. The Swiss drugmaker maintained its full-year guidance and awaits late-stage data on three experimental drugs.
Jul 28, 2026
The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.
Jun 27, 2026
Mexico and Finland cut clinical trial approvals to 30 days; the EU Biotech Act proposes faster timelines and harmonized rules. Finland will also establish FinTrials to boost clinical research.
Jul 30, 2026
Zemcelpro (dorocubicel) has achieved NUB Status 1 in Germany, enabling hospitals to seek temporary reimbursement, while Cordex Biologics expanded access to Asia and Argentina through a distribution deal with FarmaMondo. The cell therapy holds conditional EU authorization for certain blood cancers.
Jun 22, 2026
Regeneron announced FDA and EMA review acceptance for cemdisiran in generalized myasthenia gravis and FDA priority review acceptance for garetosmab in fibrodysplasia ossificans progressiva. The garetosmab BLA is supported by Phase 3 OPTIMA trial data showing 94% and 90% reductions in new bone lesions.
May 14, 2026
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
May 12, 2026
Rhythm reported Q1 2026 IMCIVREE revenue of $60.1 million and said more than 150 patient start forms were received after U.S. approval in acquired hypothalamic obesity. The company also cited European authorization and a Japanese application under review.
May 07, 2026
Merck's Enflonsia (clesrovimab) receives EU approval for RSV prevention in infants. Separately, researchers identify a monoclonal antibody cocktail from pediatricians' immune cells that shows potent protection against RSV and hMPV in animal studies.
May 06, 2026
X4 Pharmaceuticals is on track to complete enrollment of its Phase 3 4WARD trial for mavorixafor in chronic neutropenia by Q3 2026, targeting a 2028 launch. The European Commission approved XOLREMDI for WHIM syndrome, while the company cuts costs and deprioritizes WHIM commercialization.
