Biologics
Pharmaceuticals

Teva wins FDA approval for DEGEVMA denosumab biosimilar to Xgeva

Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Pharmaceuticals
Genomics
Regulatory Science

Oryzon secures EMA approval to start HOPE-2 vafidemstat trial in PMS

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Pharmaceuticals
Biologics

SCYNEXIS wins $214m BARDA contract to develop SCY-247 antifungal

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
Bioprocessing
Pharmaceuticals

Lifecore Biomedical to go private in $664m Webster Equity deal

Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
Medical Devices

IBA to install first gantry proton therapy centre in central Italy

IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
Pharmaceuticals
Biotech

Addex Therapeutics posts H1 2026 loss as cash falls to CHF 0.8m

Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject expands board and hires ex-FDA lead ahead of ZEPIZURE launch

The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
Biologics
Pharmaceuticals

Annexon to present ARCHER II baseline data at Retina Society meeting

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Medical Devices
Diagnostics
Pharmaceuticals
Cell & Gene Therapy
Biologics

Penn Medicine and IBA form Noventra Oncology Alliance JV

The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
Pharmaceuticals
Biologics
Diagnostics

ITM reports re-treatment and dosimetry data for ITM-11 at ASTRO

Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen's OCU400 gains provisional approval in The Bahamas for RP

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Digital Health

Ingenio Care launches AI-enabled national healthcare marketplace

The Illinois-based digital health company says its marketplace lists over 7.5 million US providers with CMS pricing and quality data.
The Illinois-based digital health company says its marketplace lists over 7.5 million US providers with CMS pricing and quality data.
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