Daily18 小时
FDA Approves First Gene Therapy for Treatment of AADC deficiency
The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus ...
BridgeBio: 2 Weeks Until Major Drug Approval Catalyst - A Buy, With Caveats
BridgeBio Pharma’s acoramidis shows improved survival data, boosting approval chances. Read why BBIO stock could see gains if ...
Autolus wins FDA approval of Aucatzyl for acute lymphoblastic leukemia
FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...
FDA Approves Renewal of Canalevia-CA1, Jaguar Health’s Drug for Chemotherapy-Induced ...
CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA ...
FDA-approved procedure helps regrow knee cartilage, easing pain
Dr. Rick Lehman performs the MACI procedure, which uses the patient's own cells to regrow cartilage in the knee, eliminating ...
MassDevice23 天
FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter
The Affera mapping and ablation system with the Sphere-9 catheter [Images courtesy of Medtronic] Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system ...
PR Newswire2 天
Implantica submits FDA PMA application Clinical Module 2 for RefluxStop™ for U.S. market ...
a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion ...
PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted ...
PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification ...
pharmaphorum2 天
FDA changes its mind and approves Takeda’s Eohilia
In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE). The US regulator has cleared ...
JD Supra7 天
FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside ...
On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, ...
PharmTech24 天
FDA Approves RSV Vaccine
Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at ...