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FDA Approves Triumeq PD for Children With HIV
FDA Approves Triumeq PD for Children With HIV
The FDA has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir, and lamivudine treatment (Triumeq PD; ViiV Healthcare...
FDA Grants Fast Track Designation to ASC Therapeutics’ Gene Therapy for Hemophilia A
FDA Grants Fast Track Designation to ASC Therapeutics’ Gene Therapy for Hemophilia A

The U.S. Food and Drug Administration granted Fast Track designation for ASC Therapeutics’ ASC618, a second-generation gene therapy of hemophilia A.

Vuity From Allergan
Vuity From Allergan

The FDA has approved pilocarpine hydrochloride ophthalmic solution 1.25% (Vuity, Allergan, an AbbVie company) to treat presbyopia in adults.

Genentech: Phase 3 Study of Immunotherapy in ES-SCLC Fails to Meet Co-primary Endpoint
Genentech: Phase 3 Study of Immunotherapy in ES-SCLC Fails to Meet Co-primary Endpoint
The phase 3 SKYSCRAPER-02 study, which evaluated the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initi...
Baricitinib Produces Significant Hair Regrowth in Adults With Severe Alopecia Areata
Baricitinib Produces Significant Hair Regrowth in Adults With Severe Alopecia Areata
Baricitinib (Olumiant; Eli Lilly and Incyte ) was found to produce significant hair regrowth on the scalp, eyelashes, and eyebrows of adults with severe alopecia areata. ...
FDA Grants Priority Review to Futibatinib for Metastatic Cholangiocarcinoma
FDA Grants Priority Review to Futibatinib for Metastatic Cholangiocarcinoma
The FDA has granted priority review to a New Drug Application (NDA) for Taiho Oncology, Inc’s futibatinib (TAS-120) in the treatment of patients with previously treated locally advanced or metas...
Researchers redefine the mechanisms of Dravet syndrome
Researchers redefine the mechanisms of Dravet syndrome
Researchers from Children's Hospital of Philadelphia (CHOP) have found that dysfunction in an important cell subtype in the brain's neuronal network contribute to chronic symptoms in the neurodevel...
FDA requests nearly 34% increase in funding as part of the President’s fiscal year 2023 budget
FDA requests nearly 34% increase in funding as part of the President’s fiscal year 2023 budget
Today, the U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President's fiscal year (FY) 2023 budget - a nearly 34% ($2.1 billion) increase...
Telix’s TLX66 Gets Orphan Drug Designation for HSCT PatientsTelix’s TLX66 Gets Orphan Drug Designation for HSCT Patients
Telix’s TLX66 Gets Orphan Drug Designation for HSCT PatientsTelix’s TLX66 Gets Orphan Drug Designation for HSCT Patients
The FDA has granted Telix Pharmaceuticals an Orphan Drug designation for its monoclonal antibody, TLX66 (90Y-besilesomab), for conditioning treatment of patients prior to undergoing hematopoietic s...
FDA Approves Higher Dose of Novo Nordisk’s Type 2 Diabetes Drug
FDA Approves Higher Dose of Novo Nordisk’s Type 2 Diabetes Drug
The FDA has approved a 2-mg dose of Novo Nordisk’s type 2 diabetes drug Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analogue that is now available in 0.5-mg, 1-mg and 2-...
Axsome Therapeutics to Acquire Jazz Pharmaceuticals’ Sleep-Combating Drug Sunosi
Axsome Therapeutics to Acquire Jazz Pharmaceuticals’ Sleep-Combating Drug Sunosi

Jazz Pharmaceuticals agreed to divest its Sunosi (solriamfetol) drug to Axsome Therapeutics that includes an upfront payment of $53 million.

Alzheimer's leads to changes in the small blood vessels in the brain
Alzheimer's leads to changes in the small blood vessels in the brain

Earlier research has shown that several of the same risk factors behind the development of cardiovascular disease also can lead to Alzheimer’s. 

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