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FDA Approves Kisunla for Alzheimer’s Treatment FDA Discover how Kisunla (donanemab-azbt) injection, FDA-approved for Alzheimer’s treatment, reduces cognitive decline in adults with mild impairment or dementia.
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine Pfizer Discover Pfizer and BioNTech's milestone: CHMP recommends COMIRNATY? JN.1 vaccine for COVID-19, targeting Omicron JN.1 variant. Learn about enhanced efficacy, regulatory filings, and global distribution plans.
EMA Approves First Nasal Spray for Anaphylaxis EMA Discover Eurneffy, the first nasal spray recommended by the EMA for anaphylaxis treatment. Learn about its needle-free convenience and clinical effectiveness in severe allergic reactions.
EMA's CHMP June 2024 Approvals and Recommendations EMA In June 2024, the EMA's CHMP recommended 10 new medicines for approval, including Balversa for urothelial carcinoma and Eurneffy, the first nasal spray for allergic reactions. Notable approvals also include mResvia, an mRNA vaccine for RSV, and treatments for various cancers and rare diseases.
SKYRIZI? Approved for Ulcerative Colitis Treatment by FDA Abbvie FDA SKYRIZI? (risankizumab-rzaa) approval by the FDA marks a milestone in treating ulcerative colitis and Crohn's disease, highlighting clinical trials, impact on patients, and safety considerations.
EMA Initiates Review of Painkiller Metamizole EMA EMA launches review of metamizole medications due to agranulocytosis risk concerns. Learn about the review process, reasons, and potential impact on EU authorizations.
FDA Approves Repotrectinib (Augtyro) for NTRK FDA The FDA granted accelerated approval to repotrectinib (Augtyro) for adults and children aged 12+ with NTRK fusion-positive tumors. The TRIDENT-1 trial showed a 58% ORR in TKI-na?ve patients and a 50% ORR in TKI-pretreated patients, highlighting its efficacy and potential.
FDA Approves Imetelstat for Low- to Intermediate-1 Risk MDS FDA On June 6, 2024, the FDA approved imetelstat (Rytelo) for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) and transfusion-dependent anemia. The approval is based on significant trial results demonstrating RBC transfusion independence.
Johnson&Johnson Seeks FDA and EMA Approval for Expanded Pediatric Use of HIV Drug Johnson & Johnson Johnson & Johnson submits sNDA to FDA for expanding PREZCOBIX? use in HIV-1 infected children aged 6+ years and weighing at least 25 kg, aiming to provide new treatment options.
AbbVie Introduces RINVOQ? for Pediatric Joint Diseases AbbVie AbbVie announces RINVOQ? (upadacitinib) approval for pediatric polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) in the U.S., introducing RINVOQ? LQ oral solution.