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Medical Dialogues4h

FDA Approves Skytrofa for Adult Growth Hormone Deficiency

The FDA has approved Skytrofa® (lonapegsomatropin-tcgd) for treating adults with growth hormone deficiency (GHD).This ...
CURE4h

FDA Grants Orphan Drug Status to VT3989 for Mesothelioma Treatment

The FDA awarded orphan drug designation to VT3989 for mesothelioma, supporting the experimental cancer treatment’s ...
Pharmaceutical Technology on MSN1d

Ascendis Pharma’s Skytrofa gains FDA approval for growth hormone deficiency

The US Food and Drug Administration (FDA) has granted approval for Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, ...

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
Cancer Therapy Advisor15h

Tabelecleucel Under Review Again for EBV+ PTLD

The FDA has accepted for priority review the resubmitted BLA for tabelecleucel to treat patients 2 years of age and older with EBV+ PTLD who have received at least 1 prior therapy.

Sephience Gets FDA Approval, Now A Key Revenue Driver For PTC Therapeutics

PTC Therapeutics secures FDA approval for Sephience in PKU, launching August with analysts projecting strong revenue and ...
Medscape7d

Delgocitinib Approved by FDA for Chronic Hand Eczema

The topical JAK inhibitor is the first treatment approved specifically for adults with moderate-to-severe chronic hand eczema.

Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally approved for CID, to regulatory approval and commercialization for general ...