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Home»Posts tagged with»United States Food and Drug Administration (Page 2)

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

By Pallavi Madhiraju on April 24, 2026   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.

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

By Pallavi Madhiraju on April 22, 2026   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.

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

By Pallavi Madhiraju on April 12, 2026   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.

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

By Pallavi Madhiraju on April 11, 2026   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.

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

By Pallavi Madhiraju on April 11, 2026   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.

Can Lupin Limited gain ground in cardiometabolic generics with United States dapagliflozin launch?

By Pallavi Madhiraju on April 11, 2026   Pharma & Biotech  

Can Lupin Limited gain ground in cardiometabolic generics with United States dapagliflozin launch?

Lupin Limited has launched generic dapagliflozin in the United States. Read what it means for Farxiga, pricing pressure, and market access.

Eli Lilly and Company’s Foundayo approval could widen the obesity market faster than rivals expected

By Pallavi Madhiraju on April 3, 2026   Pharma & Biotech  

Eli Lilly and Company’s Foundayo approval could widen the obesity market faster than rivals expected

Eli Lilly and Company’s Foundayo approval could reshape obesity treatment. Read what the oral GLP-1 launch changes for clinicians, payers, and rivals.

Lupin Limited moves closer to the Wakix market as pitolisant tentative approval sharpens future optionality

By Pallavi Madhiraju on March 26, 2026   Pharma & Biotech  

Lupin Limited moves closer to the Wakix market as pitolisant tentative approval sharpens future optionality

Lupin Limited has won tentative FDA approval for pitolisant tablets. Read why timing, exclusivity, and Wakix market dynamics matter next.

What AEON Biopharma Inc.’s analytical strategy reveals about the future of botulinum toxin biosimilars

By Soujanya Ravi on March 25, 2026   Pharma & Biotech  

What AEON Biopharma Inc.’s analytical strategy reveals about the future of botulinum toxin biosimilars

AEON Biopharma advances ABP-450 biosimilar strategy. Discover what this means for BOTOX competition and future complex biologics markets.

Biofrontera targets U.S. label expansion for Ameluz in trunk and extremities

By Soujanya Ravi on February 17, 2026   Pharma & Biotech  

Biofrontera targets U.S. label expansion for Ameluz in trunk and extremities

Phase 1 PK data bring Ameluz closer to broader FDA review. Explore the regulatory stakes and market impact in actinic keratosis.

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