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United States Food and Drug Administration

PharmaDeviceNews United States Food and Drug Administration
Representative image of pharmaceutical quality control and drug manufacturing, reflecting Concord Biotech’s United States Food and Drug Administration approval for Mycophenolate Mofetil oral suspension and the market focus on its transplant immunosuppressant portfolio.
Pharma & Biotech

Can Mycophenolate Mofetil approval strengthen Concord Biotech’s United States generics strategy?

Find out how Concord Biotech’s FDA approval for Mycophenolate Mofetil could reshape its transplant generics strategy.

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Representative image of liver disease drug research and clinical data analysis. Zydus’ FDA Priority Review for saroglitazar highlights the growing treatment competition in primary biliary cholangitis.
Pharma & Biotech

Zydus gains FDA Priority Review for saroglitazar as PBC treatment competition intensifies

Zydus’ saroglitazar gets FDA Priority Review in PBC, setting up a key test for dual PPAR therapy in rare liver disease.

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Representative image of Alzheimer’s disease treatment and market analysis, highlighting how Eisai’s Leqembi sales simulation could shape BioArctic’s royalty outlook, investor sentiment and the commercial future of anti-amyloid therapies.
Pharma & Biotech

Leqembi’s sales curve just got a new number. BioArctic investors may not ignore it

Leqembi’s Alzheimer’s rollout is still slow, but Eisai’s 2028 sales simulation keeps BioArctic’s royalty story alive.

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Medical Devices & Diagnostics

Can Chest Wall Innovations turn FDA clearance into adoption in rib fixation?

Rib fixation is gaining clinical ground. Chest Wall Innovations now faces the harder test: converting FDA clearance into surgeon adoption.

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Pharma & Biotech

Paradigm Health’s FDA collaboration puts clinical trial data automation under the spotlight

FDA review is moving closer to real time. Paradigm Health’s pilot with Amgen and AstraZeneca could reset clinical trial infrastructure.

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Pharma & Biotech

Cipla just cracked a $1.5bn U.S. inhaler market. Here’s why it matters

Find out how Cipla’s U.S. FDA approval for generic Ventolin HFA strengthens its respiratory portfolio and inhaler manufacturing strategy.

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Merck’s IDVYNSO approval adds a new HIV option, but the real battle starts after viral suppression
Pharma & Biotech

FDA approval of IDVYNSO gives Merck a fresh HIV story, but will clinicians switch stable patients?

Merck’s IDVYNSO has won FDA approval in HIV. Read what the new two-drug regimen changes, where it fits, and what risks still matter.

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Pharma & Biotech

Why Corcept Therapeutics now faces a bigger execution test after Lifyorli’s ROSELLA success

Corcept Therapeutics’ Lifyorli showed strong survival benefit in ovarian cancer. Read what the ROSELLA data could change for clinicians and payers.

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Plus Therapeutics REYOBIQ orphan drug designation in pediatric malignant gliomas highlights growing interest in targeted CNS cancer therapies for rare childhood brain tumors. Representative image.
Pharma & Biotech

Can REYOBIQ improve Plus Therapeutics’ path in pediatric high-grade glioma and ependymoma?

Plus Therapeutics won orphan drug designation for REYOBIQ in pediatric malignant gliomas. Read what it changes for CNS cancer development.

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Pharma & Biotech

Can Apotex crack the complex generic code for semaglutide before the glucagon-like peptide-1 market resets?

Apotex won first tentative U.S. approval for generic semaglutide. Read what it could mean for glucagon-like peptide-1 access, pricing, and competition.

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