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FDA approval

PharmaDeviceNews FDA approval
Representative image: Clinicians review lung cancer genomic testing data and blood-based diagnostic results, reflecting Guardant Health’s Guardant360 CDx FDA approval as a companion diagnostic for HERNEXEOS in HER2-mutant advanced non-small cell lung cancer.
Medical Devices & Diagnostics

How Guardant360 CDx approval supports Boehringer Ingelheim’s HERNEXEOS launch strategy

Find out how Guardant360 CDx approval could expand liquid biopsy use in HER2-mutant advanced lung cancer treatment selection.

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Representative image of a modern pathology laboratory where automated PD-L1 cancer diagnostic testing is supporting faster immuno-oncology treatment decisions, reflecting Agilent Technologies’ expanded FDA approval for PD-L1 IHC 22C3 pharmDx on the Dako Omnis platform.
Medical Devices & Diagnostics

Agilent wins FDA backing to move more Keytruda-linked PD-L1 testing onto Dako Omnis

Find out how Agilent’s expanded PD-L1 test approval could change automated cancer diagnostics and oncology lab workflows.

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Pharma & Biotech

AstraZeneca’s Imfinzi gains a first-mover edge in high-risk non-muscle-invasive bladder cancer

Imfinzi has FDA approval with BCG in early high-risk bladder cancer. The next test is adoption, recurrence data and real-world use.

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Representative image of an oncology researcher reviewing colorectal cancer scan data, reflecting Pfizer’s Braftovi regimen update in BRAF V600E-mutant metastatic colorectal cancer.
Pharma & Biotech

Is Pfizer’s Braftovi regimen becoming the new benchmark for BRAF-mutant colorectal cancer?

Pfizer’s Braftovi data strengthen its role in BRAF V600E metastatic colorectal cancer. Find out what this could change next.

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Representative image showing a clinician reviewing joint health with a patient, reflecting Johnson & Johnson’s Tremfya FDA label expansion for structural joint damage inhibition in active psoriatic arthritis.
Pharma & Biotech

Can Tremfya turn radiographic evidence into a commercial advantage for Johnson & Johnson?

Find out how Johnson & Johnson’s Tremfya label expansion could reshape IL-23 competition in psoriatic arthritis care.

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Representative image of oncology research and blood cancer diagnostics. AbbVie’s DECNUPAZ approval highlights how CD123-targeted antibody-drug conjugates could reshape treatment options for blastic plasmacytoid dendritic cell neoplasm.
Pharma & Biotech

How AbbVie’s DECNUPAZ approval changes the treatment conversation in aggressive BPDCN

Find out how AbbVie’s DECNUPAZ approval could change BPDCN treatment while raising new safety and adoption questions.

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Galderma wins FDA approval for Differin Epiduo OTC switch as acne treatment access expands
Pharma & Biotech

Why Galderma’s acne gel approval could quietly reset the over the counter dermatology market

Acne care is moving from prescription desks to retail shelves. Galderma’s Differin Epiduo switch tests how far OTC dermatology can go.

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Representative image: A clinician reviews prescribing and dosing data for an injectable rare disease therapy, reflecting Kyowa Kirin’s FDA-approved Crysvita dosing update for adults with X-linked hypophosphatemia.
Pharma & Biotech

What Kyowa Kirin’s Crysvita dosing change reveals about rare disease treatment individualisation

Rare disease dosing is becoming more personalised. Kyowa Kirin’s Crysvita update tests how far flexibility can improve adult XLH care.

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Pharma & Biotech

FDA approval of Bizengri gives Partner Therapeutics a broader rare-oncology opportunity

Rare cancer biology met regulatory urgency. Bizengri’s approval tests whether precision oncology can reach tiny patient subsets fast.

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Representative image: A clinician discusses neuromuscular treatment options with an adult patient as Argenx SE’s expanded Vyvgart approval broadens the FDA label across all adult generalized myasthenia gravis serotypes, strengthening interest in targeted FcRn therapies for autoimmune neurology.
Pharma & Biotech

Why Argenx’s broader Vyvgart label changes the treatment equation in generalized myasthenia gravis

Vyvgart now covers all adult gMG serotypes. Argenx gains a wider label, but payers and real-world durability remain the next test.

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