Pharma News, 2022

First and only long-acting C5 inhibitor has demonstrated early onset and sustained clinical benefit, and may reduce treatment burden with dosing every 8 weeks. ...

Kinnate Biopharma Inc. (Nasdaq: KNTE), a clinical-stage precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnateâ€...

The European Commission (EC) has approved AstraZeneca’s Tezspire (tezepelumab) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled...

Rocket Pharmaceuticals is expanding its reach into gene therapies with the purchase of Massachusetts-based Renovacor in a deal valued at approximately $53 million. ...

The FDA approved Fennec Pharma’s Pedmark (sodium thiosulfate injection) for reducing the risk of hearing loss associated with cisplatin in pediatric patients aged one month and older with localiz...

The FDA’s Oncologic Drugs Advisory Committee meeting on Thursday will likely be a slaughter for two biopharma companies, Spectrum Pharmaceuticals and Oncopeptides, as reviewers today raised signi...

Seagen Inc. SGEN recently announced that the FDA has accepted for priority review its supplemental new drug application (sNDA) for its marketed drug, Tukysa (tucatinib), in combination with Roche's...

Patients with pancreatic cancer may benefit from treatment with ATG-101, which was granted orphan drug designation by the FDA.

The FDA has approved Heron Therapeutics’ Aponvie (aprepitant) for the prevention of postoperative nausea and vomiting (PONV), common adverse effects of anesthesia and surgery. ...

The US Food and Drug Administration (FDA) has granted accelerated approval to the new gene therapy elivaldogene autotemcel (Skysona, bluebird bio) for the treatment of cerebral adrenoleukodystrophy...

Aurinia Pharma and partner Otsuka have secured approval in the EU for Lupkynis, billed as the first oral treatment for active nephritis in patients with the autoimmune disease systemic lupus erythe...

With deal, drug wholesaler grows its biopharma services platform.