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Apellis Gets FDA Priority Review for EMPAVELI in C3G, IC-MPGN

Apr 2, 2025
Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application…
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AIRNA Secures $155M in Oversubscribed Series B for Alpha-1 Antitrypsin Trial

Apr 2, 2025
AIRNA, a biotech company pioneering RNA editing therapeutics to transform the lives of patients with rare and common conditions, announced the closing of an oversubscribed $155 million…
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Amneal Launches BORUZU, First Ready-to-Use Bortezomib Injection

Apr 2, 2025
Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or…
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Bavarian Nordic Gets FDA Approval for Smallpox, Mpox Vaccine

Apr 1, 2025
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating)…
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Qfitlia Approved as First US Therapy for Hemophilia A/B with or without Inhibitors

Apr 1, 2025
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of…
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Imfinzi Approved as First Perioperative Immunotherapy for Bladder Cancer

Apr 1, 2025
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery…
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Lexicon Pharmaceuticals Signs Exclusive License Agreement with Novo Nordisk for LX9851

Mar 31, 2025
Lexicon Pharmaceuticals, Inc. announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development…
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Ionis Expands Partnership with Sobi for Olezarsen Commercialization Outside the U.S.

Mar 28, 2025
Ionis Pharmaceuticals, Inc. announced that it has entered into a license agreement under which Sobi receives exclusive rights in countries outside the U.S., Canada and China to…
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Soleno Therapeutics Wins FDA Approval for VYKAT XR to Treat Hyperphagia in Prader-Willi Syndrome

Mar 28, 2025
Soleno Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR,…
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Merck’s Subcutaneous Pembrolizumab Shows Noninferior Pharmacokinetics to IV KEYTRUDA

Mar 28, 2025
Merck, known as MSD outside of the United States and Canada, announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration…
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