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FDA’s updated TearCare indication states that the system improves meibomian gland function when thermal treatment is combined with manual gland expression, reinforcing its role in dry eye disease management. Representative image.
Medical Devices & Diagnostics

Sight Sciences wins TearCare label expansion after 345-patient SAHARA trial

FDA has updated TearCare’s indication to state that the system improves meibomian gland function when thermal treatment is combined with manual gland expression.

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AbelZeta has regained global rights to dual CD19/CD20 CAR-T therapy prizlon-cel and secured FDA IND clearance, supported by early Chinese clinical data reporting a 91.5% response rate. Representative image.
Pharma & Biotech

Prizlon-cel reaches US clinical development as AbelZeta rebuilds its large B-cell lymphoma strategy.

AbelZeta has regained global rights to dual CD19/CD20 CAR-T prizlon-cel and received FDA IND clearance, backed by early Chinese data reporting a 91.5% response rate.

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Femasys’ FemBloc has secured FDA agreement on a modular PMA pathway, allowing manufacturing and nonclinical sections to be reviewed ahead of completion of pivotal FINALE pregnancy data and potentially streamlining the device’s regulatory process. Representative image.
Medical Devices & Diagnostics

Can permanent birth control move into the OB-GYN office? FemBloc gets a clearer FDA pathway.

FDA has agreed to Femasys’ modular PMA approach for FemBloc, allowing manufacturing and nonclinical portions to be reviewed before the pivotal FINALE pregnancy data are complete.

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FDA approval of a single-use LEROCHOL autoinjector and revised labeling gives LIB Therapeutics a clearer US commercialization pathway, with product availability planned by January 2027. Representative image.
Pharma & Biotech

LIB Therapeutics takes its $199-a-month PCSK9 strategy into an autoinjector for 2027

FDA has approved a single-use LEROCHOL autoinjector and revised the drug’s labeling, with LIB Therapeutics planning US availability by January 2027.

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A Nature Communications study found Vascudyne’s externally supported bioengineered vessel remained patent for up to 550 days in sheep, including about a year without anticoagulation, supporting further evaluation of its long-term vascular graft potential. Representative image.
Medical Devices & Diagnostics

Could CABG stop depending on harvested veins? Vascudyne’s 18-month data strengthen the case.

A Nature Communications study found Vascudyne’s externally supported bioengineered vessel remained patent for up to 550 days in sheep, including a year without anticoagulation.

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Alvotech can receive up to about $150 million while retaining US commercialization rights to biosimilar candidates AVT34 and AVT87, marking a strategic shift in how the company approaches the American biosimilars market. Representative image.
Pharma & Biotech

Alvotech-Lotus $150m biosimilar deal targets nearly $12 billion of Imfinzi and Hemlibra sales

Alvotech can receive up to about $150 million while retaining the right to sell AVT34 and AVT87 itself in the United States, a first for its US biosimilar strategy.

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NICE support for routine NHS access to ex-situ liver machine perfusion could reduce funding variation while expanding use of technology designed to assess and preserve donor livers before transplantation. Representative image.
Medical Devices & Diagnostics

OrganOx metra gains a reimbursement tailwind as NICE backs machine perfusion across NHS liver transplantation

NICE has supported routine NHS access to ex-situ liver machine perfusion, potentially reducing funding variation for technology designed to assess and preserve donor organs before transplantation.

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European approval of teclistamab plus daratumumab follows MajesTEC-3 results showing an 83.4% reduction in the risk of progression or death and a significant overall-survival advantage versus established multiple myeloma regimens. Representative image.
Pharma & Biotech

Johnson & Johnson wins EU approval for TECVAYLI-DARZALEX as myeloma treatment moves earlier

Europe has approved teclistamab plus daratumumab after MajesTEC-3 showed an 83.4% reduction in progression or death and a significant overall-survival advantage versus established regimens.

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The 85-patient BCI-REHAB study found a 4.5-point treatment difference favoring IpsiHand and a number needed to treat of 2.2, although substantial control-group withdrawal complicates interpretation of the rehabilitation results. Representative image.
Medical Devices & Diagnostics

Kandu’s IpsiHand BCI improves chronic stroke arm function in randomized trial, but 17 control patients dropping out matters

The 85-patient BCI-REHAB study found a 4.5-point treatment difference favoring IpsiHand and a number needed to treat of 2.2, although substantial control-group withdrawal complicates interpretation.

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Sandoz has secured ex-China commercialization rights to an initial biosimilar portfolio under a collaboration worth up to $322 million, while Henlius retains responsibility for development, manufacturing and supply. Representative image.
Pharma & Biotech

Sandoz-Henlius $322m biosimilar deal starts with three blockbusters and could expand to 10 assets

Sandoz gains ex-China commercialization rights to an initial biosimilar portfolio while Henlius retains development, manufacturing and supply responsibilities under a collaboration worth up to $322 million.

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