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Homepage > Company > Media > Pharma News > 2022

Pharma News, 2022

Ultomiris approved in Europe for the treatment of adults with generalised myasthenia gravis
Ultomiris approved in Europe for the treatment of adults with generalised myasthenia gravis
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. Receives Fast Track Designation from the U.S. FDA for KIN-2787, an Investigational Pan-RAF Inhibitor
Kinnate Biopharma Inc. Receives Fast Track Designation from the U.S. FDA for KIN-2787, an Investigational Pan-RAF Inhibitor
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€...
EC Approves AstraZeneca’s Tezspire for Severe Asthma
EC Approves AstraZeneca’s Tezspire for Severe Asthma
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 to Acquire Renovacor, Extending Leadership in AAV-based Cardiac Gene Therapy
Rocket Pharmaceuticals to Acquire Renovacor, Extending Leadership in AAV-based Cardiac Gene Therapy
Rocket Pharmaceuticals is expanding its reach into gene therapies with the purchase of Massachusetts-based Renovacor in a deal valued at approximately $53 million. ...
Fennec Pharma Receives FDA Approval of Pedmark
Fennec Pharma Receives FDA Approval of Pedmark
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...
FDA slams Spectrum and Oncopeptides cancer drugs over efficacy concerns ahead of ODAC meeting
FDA slams Spectrum and Oncopeptides cancer drugs over efficacy concerns ahead of ODAC meeting
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's (SGEN) Tukysa Gets FDA Priority Review for New Indication
Seagen's (SGEN) Tukysa Gets FDA Priority Review for New Indication
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...
FDA Grants Orphan Drug Designation to ATG-101 for Pancreatic Cancer
FDA Grants Orphan Drug Designation to ATG-101 for Pancreatic Cancer

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

FDA Approves Heron’s Aponvie for Postoperative Nausea
FDA Approves Heron’s Aponvie for Postoperative Nausea
The FDA has approved Heron Therapeutics’ Aponvie (aprepitant) for the prevention of postoperative nausea and vomiting (PONV), common adverse effects of anesthesia and surgery. ...
FDA Fast Tracks Approval of Novel Therapy for Rare Neurologic Disorder
FDA Fast Tracks Approval of Novel Therapy for Rare Neurologic Disorder
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...
Otsuka, Aurinia claim EU okay for oral lupus nephritis drug
Otsuka, Aurinia claim EU okay for oral lupus nephritis drug
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...
AmerisourceBergen Acquires PharmaLex for $1.28 Billion
AmerisourceBergen Acquires PharmaLex for $1.28 Billion
With deal, drug wholesaler grows its biopharma services platform.
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