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Home»Posts tagged with»FDA approval (Page 2)

SOLVD Health broadens AvertD access as FDA clears blood-based sample collection

By Pallavi Madhiraju on April 22, 2026   Medical Devices & Diagnostics  

SOLVD Health broadens AvertD access as FDA clears blood-based sample collection

FDA cleared blood-based collection for SOLVD Health’s AvertD. Find out why this could expand genetic opioid risk testing in surgical care.

How Agilent’s PD-L1 companion diagnostic now shapes pembrolizumab access in esophageal carcinoma

By Pallavi Madhiraju on March 27, 2026   Pharma & Biotech  

How Agilent’s PD-L1 companion diagnostic now shapes pembrolizumab access in esophageal carcinoma

FDA approves Agilent’s PD-L1 IHC 22C3 pharmDx for esophageal and GEJ carcinoma, marking the eighth companion diagnostic indication alongside pembrolizumab. Read the analysis.

How Galderma is repositioning Restylane Contour beyond cheeks into full-face structural correction

By Pallavi Madhiraju on March 23, 2026   Pharma & Biotech  

How Galderma is repositioning Restylane Contour beyond cheeks into full-face structural correction

FDA approval of Restylane Contour for temple hollowing signals a shift in facial aesthetics. Discover what this means for the industry and future treatments.

LivaNova PLC expands sleep apnea eligibility as aura6000 gains FDA approval without CCC limits

By Pallavi Madhiraju on March 22, 2026   Medical Devices & Diagnostics  

LivaNova PLC expands sleep apnea eligibility as aura6000 gains FDA approval without CCC limits

LivaNova PLC secures FDA approval for aura6000. Discover how it could reshape sleep apnea treatment and expand patient eligibility.

How Bristol Myers Squibb’s Opdivo approvals in frontline and relapsed classical Hodgkin lymphoma reset treatment pathways

By Pallavi Madhiraju on March 21, 2026   Pharma & Biotech  

How Bristol Myers Squibb’s Opdivo approvals in frontline and relapsed classical Hodgkin lymphoma reset treatment pathways

Nivolumab wins U.S. frontline and EU relapsed cHL approvals. Analyse what the dual verdict means for sequencing, safety, and reimbursement.

J&J’s Tecvayli-Darzalex Faspro combination approved for myeloma after MajesTEC-3 Phase 3 results

By Pallavi Madhiraju on March 6, 2026   Pharma & Biotech  

J&J’s Tecvayli-Darzalex Faspro combination approved for myeloma after MajesTEC-3 Phase 3 results

FDA approves J&J’s teclistamab plus daratumumab for relapsed myeloma from second line. Analyse the MajesTEC-3 data, safety profile, and what this changes for treatment.

Can Acadia overturn EMA’s negative opinion on trofinetide for Rett syndrome?

By Pallavi Madhiraju on March 3, 2026   Pharma & Biotech  

Can Acadia overturn EMA’s negative opinion on trofinetide for Rett syndrome?

Acadia seeks EU re-examination after CHMP rejects trofinetide for Rett syndrome. Read the regulatory and clinical implications.

Organon & Co. strengthens LARC strategy with MIUDELLA license from Sebela Pharmaceuticals

By Pallavi Madhiraju on February 28, 2026   Medical Devices & Diagnostics  

Organon & Co. strengthens LARC strategy with MIUDELLA license from Sebela Pharmaceuticals

Organon & Co. licenses MIUDELLA copper IUD. Explore what this means for hormone-free contraception and LARC competition. Read the analysis.

Eton Pharmaceuticals expands rare endocrine portfolio with FDA-backed liquid desmopressin

By Soujanya Ravi on February 26, 2026   Pharma & Biotech  

Eton Pharmaceuticals expands rare endocrine portfolio with FDA-backed liquid desmopressin

FDA approves DESMODA oral solution for central diabetes insipidus. Explore what this means for dosing precision and rare endocrine care.

FDA approval of milsaperidone puts Vanda Pharmaceuticals into crowded bipolar I disorder and schizophrenia markets

By Pallavi Madhiraju on February 21, 2026   Pharma & Biotech  

FDA approval of milsaperidone puts Vanda Pharmaceuticals into crowded bipolar I disorder and schizophrenia markets

FDA approves milsaperidone for bipolar I disorder and schizophrenia. Explore what this means for psychiatry, competition, and Vanda Pharmaceuticals’ strategy.

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