Aquestive Therapeutics to Present New Findings on Anaphylmâ„¢ (Epinephrine Sublingual Film) at the 2025 AAAAI Annual Meeting
Data show Anaphylm maintains consistent stability and potency under extreme temperature and real-world conditions, including heat, freezing, and ...
Fierce Pharma2h
Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
Medscape1d
FDA Approves Mirdametinib for Neurofibromatosis Type 1
The kinase inhibitor is now approved for adults and children aged ≥ 2 years with neurofibromatosis type 1 who have unresectable symptomatic plexiform neurofibromas.
Business Wire1d
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...
Contract Pharma1d
AbbVie’s EMBLAVEO Approved by FDA for Treatment of Complicated Intra-Abdominal Infections
Addresses the significant threat of antimicrobial resistance.
FACT CHECK: Is The FDA Banning Cosmic Brownies?
A post shared on Facebook claims the U.S. Food and Drug Administration (FDA) is purportedly banning Cosmic Brownies. Verdict: ...
Fierce Pharma7d
Supernus' 4th try proves the charm with long-awaited FDA approval for Parkinson's infusion pump Onapgo
Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump. | The device is ...
Nature8d
The science behind the first pig-organ transplant trial in humans
The small trial will help to establish whether kidneys from genetically modified pigs can be transplanted into people safely and effectively.
Medscape9d
FDA Approves Third Tocilizumab Biosimilar
The biosimilar will be available in both subcutaneous and intravenous formulations and has nearly all the same indications as ...