Aligos Therapeutics Licenses Pevifoscorvir Sodium to Xiamen Amoytop Biotech for Greater China
Aligos Therapeutics signed an exclusive license with Xiamen Amoytop Biotech to develop and commercialize its hepatitis B candidate pevifoscorvir sodium in Greater China. The agreement provides Aligos with a $25 million upfront payment and up to $420 million in milestone fees, plus high single‑digit royalties on sales. Aligos retains rights in the United States, Europe, Japan, South Korea and other markets, as well as the ability to run clinical trials in China. The drug is currently in a Phase IIB SUPREME trial comparing it to tenofovir, with interim data due in late 2026 and topline results expected in 2027.
Interna Therapeutics Collaborates with Daiichi Sankyo to Develop MNM-Based Targeted Delivery Technologies
Interna Therapeutics announced a research collaboration with Daiichi Sankyo’s Boston Research Institute to evaluate its MNM (Molecular Nanoparticle Matrix) technology as a delivery enhancer for targeted therapeutics. The partnership will integrate MNM molecules with Daiichi Sankyo’s targeting approaches, beginning with...
LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema
LEO Pharma announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Anzupgo (delgocitinib) cream targeting adolescents aged 12 to 17 with moderate‑to‑severe chronic hand eczema. The acceptance follows the Phase III DELTA TEEN trial, which...
CareDx to Divest Lab Products Unit to EuroBio Scientific for $170M
CareDx announced a definitive agreement to sell its Lab Products business, which includes PCR and next‑generation sequencing transplant diagnostics, to EuroBio Scientific for $170 million in cash. The divestiture allows CareDx to streamline operations and concentrate on its core Precision Medicine...
AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia
The U.S. Food and Drug Administration has granted approval for Rapiblyk (landiolol) for pediatric patients from birth through 17 years old suffering from supraventricular tachycardia (SVT). The decision follows the LANDI‑PED trial, which enrolled 60 children and demonstrated a greater...
ARS Pharmaceuticals Reports Health Canada Approval of Neffy 2mg to Treat Type I Allergic Reactions
Health Canada has approved ARS Pharma’s neffy 2 mg adrenaline nasal spray for adults and children weighing over 30 kg, marking the first needle‑free emergency treatment for anaphylaxis in the country. In November 2024, ARS granted ALK exclusive rights to commercialize neffy...
TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test
TOBY has received FDA Breakthrough Device Designation for its urine‑based Multi‑Cancer Early Detection (MCED) test. The non‑invasive platform analyzes volatile organic compounds in a single urine sample using spectroscopy and machine‑learning algorithms to identify multiple cancer types. The designation positions...
QIAGEN Launches QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing
QIAGEN has launched the CE‑IVDR‑certified QIAstat‑Dx BCID GPF Plus AMR Panel for rapid bloodstream‑infection syndromic testing. The assay detects 20 gram‑positive bacterial and fungal targets and ten antimicrobial‑resistance markers, delivering results in approximately one hour. Announced at the ESCMID Global...
Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma
Partner Therapeutics has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Bizengri (zenocutuzumab‑zbco), a monoclonal antibody designed for adults with advanced unresectable or metastatic cholangiocarcinoma that carry an NRG1 gene fusion. The filing is supported by...
The US FDA New Drug Approvals in March 2026
In March 2026 the U.S. FDA approved five new therapies spanning hepatology, dermatology, rare genetics, oncology, and endocrinology. GSK’s Lynavoy treats cholestatic pruritus in primary biliary cholangitis, while Johnson & Johnson’s Icotyde targets moderate‑to‑severe plaque psoriasis. Denali Therapeutics earned accelerated...
American Industrial Partners to Acquire Avanos Medical for ~$1.272B
American Industrial Partners (AIP) has agreed to acquire Avanos Medical in an all‑cash deal valued at approximately $1.272 billion. Avanos shareholders will receive $25 per share, a 72.1% premium to the April 13 closing price. The transaction will take Avanos private and...
SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
SynOx Therapeutics announced topline data from its global Phase 3 TANGENT trial, which evaluated emactuzumab (1,000 mg every two weeks for five doses) versus placebo in patients with tenosynovial giant cell tumor (TGCT). The study met both primary efficacy endpoints, showing a...
Protaryx Medical Secures FDA Clearance for Its Transseptal Access Device
Protaryx Medical announced that the U.S. Food and Drug Administration granted 510(k) clearance for its Transseptal Puncture Device, a next‑generation system designed for minimally invasive left‑heart access. The device uses radio‑frequency guidewire technology integrated with standard electrosurgical generators and features...
Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS
Travere Therapeutics announced that the U.S. Food and Drug Administration has granted full approval to Filspari (sparsentan) for reducing proteinuria in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome. The approval...
Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC
Daiichi Sankyo and Merck have secured FDA priority review for ifinatamab deruxtecan (I‑DXd) under the Real‑Time Oncology Review and Project Orbis programs. The decision follows a successful Biologics License Application based on the Phase II IDeate‑Lung01 trial, which enrolled 187 extensive‑stage...
