Regulatory Science

TOMI Environmental's iHP decontamination technology is now authorised in Ireland, bringing its EU market approvals to 11 countries.

Teva has entered a stalking-horse bid for BXCL501, a sublingual agitation treatment under FDA review with a PDUFA date of 14 November 2026.

Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.

hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.

Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.

The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.

The FDA has set a 30 April 2027 review deadline for NCX 470, a nitric oxide-donating bimatoprost eye drop targeting open-angle glaucoma.

Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.

INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.

Voluntary, vaguely documented US health industry agreements on drug prices and nutrition may fade without federal enforcement mechanisms, analysts warn.

Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.

The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.

The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.

Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.

Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.

Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.

The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.

The Austin-based biotech said the designation supports its inhaled Caveolin-1 peptide, with Phase 2 interim data expected in the second half of 2026.

The FDA has accepted Teva's NDA for ecopipam with a PDUFA date in Q1 2027, potentially the first new Tourette's therapy in over