Abeona Therapeutics faces a pivotal FDA decision after a CRL-led crash and partial rebound in pz-cel’s valuation. Check out ...

The FDA has approved Krystal Biotech’s gene therapy Vyjuvek for dystrophic epidermolysis bullosa (DEB), a rare genetic disease characterised by fragile skin that can split and blister even with ...

Gene therapy for cystic fibrosis is advancing fast. Explore key biotech players, clinical progress, and its potential to ...

Jeune Aesthetics, Inc. ("Jeune"), a wholly owned subsidiary of Krystal Biotech, Inc. ("Krystal") (NASDAQ: KRYS) leveraging Krystal's clinically validated ...

After proper training on subcutaneous injection technique, the prefilled syringe may be administered by the patient or caregiver.

Abeona Therapeutics has two late-stage assets nearing FDA decisions and solid market potential despite risks. Read why ABEO ...

The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...

On March 28, the FDA approved Imfinzi for use in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Imfinzi as adjuvant treatment after radical cystectomy, ...

FDA approves Argenx's Vyvgart Hytrulo prefilled syringe for self-injection in gMG and CIDP, offering flexible dosing and expanding treatment options.

Argenx’s VYVGART Hytrulo prefilled syringe for self-injection has received FDA approval for the treatment of adult patients ...

today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA ...