FDA Places Full Hold On Aardvark’s ARD-101 Months After Voluntary Safety Pause
The FDA’s decision to place ARD-101 on full clinical hold has shifted attention toward Aardvark’s planned unblinding of Phase III data as the company reassesses the future of its lead Prader-Willi syndrome program.
Scrip - May 15, 2026

Regenxbio’s DMD Win Raises As Many Questions As It Answers
Positive gene therapy data couldn't stop a 40% share drop as investors weighed Regenxbio's limited cash runway against a murky regulatory outlook.
Scrip - May 15, 2026

‘There Is No Single, Global Go?To?Market Model For GLP?1s’ – Biocon’s Tambe Discusses Strategy
With the race for GLP-1 generics heating up in multiple territories, Biocon Ltd CEO and managing director Shreehas Tambe discusses the varying natures of global markets and the need for tailored strategies, while warning that a “race to the bottom” on pricing is not viable or responsible.
Generics Bulletin - May 15, 2026

Financing Quarterly Statistics, Q1 2026
During Q1, biopharmas brought in an aggregate $35.9bn in financing and device company fundraising totaled $3bn; while in vitro diagnostic firms and research tools players raised $256m.
In Vivo - May 15, 2026

Dexcom Targets Late 2027 G8 Launch As It Bets On Body-Adaptive CGM Technology
Dexcom unveiled the G8, a self-adapting CGM platform it calls a complete step change, while setting a 10% annual revenue growth floor through 2030. A Medicare coverage decision expected before year-end could also double its US addressable market.
Medtech Insight - May 15, 2026

Zydus-Assertio Deal: US Revenue Might Peak In 2029 But Rolvedon Promises More
Zydus' acquisition of US firm Assertio gives it an oncology asset developed by Hanmi Pharma and a growth platform. Rolvedon's US revenues might peak in 2029 as per Evaluate Pharma's data but the drug could have potential elsewhere.
Scrip - May 15, 2026

MHRA Seeks To Lead World In Digital Mental Health Guidance
At RAPS Euro Convergence 2026, the UK regulator discussed its project to remove the ambiguity between wellness apps and regulated devices.
Medtech Insight - May 15, 2026

Apotex Leapfrogs Dr Reddy’s With First Canadian Semaglutide Launch
Stealing a march on rival Dr Reddy’s, Canadian generics giant Apotex has announced the first launch of a generic version of Ozempic for diabetes in its domestic market.
Generics Bulletin - May 15, 2026

‘Seize The Global Initiative,’ MedTech Forum 2026 Tells European Leaders
Simplified regulation, more momentum towards technology adoption, better investment flows, resilience – if not quite protectionism – and above all “market access predictability in Europe.” These were the top wish-list sentiments voiced at the MedTech Forum 2026 in Stockholm, Sweden.
Medtech Insight - May 15, 2026

With Selective Targeting, HaemaLogiX Eyes Crowded Multiple Myeloma Space
HaemaLogix is backing its monoclonal antibody targeting Kappa myeloma antigen to carve out space in one of oncology's most crowded markets.
Scrip - May 15, 2026

Podcast: Kurma’s €215m Fund And What It Says About European Funding Environment
Kurma Partners closed BioFund IV at €215m, €35m short of target, as Europe's biotech sector grapples with thin early-stage capital and heavy reliance on non-European investors.
In Vivo - May 15, 2026

GlycoNex Progresses Novel Glycan-Targeted ADC To Clinic
Taiwanese biotech has high hopes of successfully mounting first glycan antibody onto an antibody-drug conjugate.
Scrip - May 15, 2026

US Consumer Health Weekly News Digest: Business, Regulation, Science
FDA notes OMUFA due date changes, nonpayment penalties; plans "dietary substance for use to supplement the diet" guidance; Makary makes consumer health mark; AHPA reports "Year of Transition & Impact"; Herbalife sales up nearly 8%; and North Carolina CBD firm's sales up nearly 20%.
HBW Insight - May 15, 2026