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Jun 16, 2026
Grifols has launched FESILTY (fibrinogen, human-chmt) in the U.S., a fibrinogen concentrate FDA-approved in December 2025 for acute bleeding episodes in patients with congenital fibrinogen deficiency. The highly purified product, developed by Biotest, enables rapid fibrinogen restoration and can be reconstituted in approximately three minutes.
May 18, 2026
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
May 14, 2026
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
Apr 19, 2026
Norovirus has been making its rounds again during the winter season, causing vomiting, diarrhea and stomach cramps that usually clear within one to three days. There is no specific medication, and hydration, bland foods and strict handwashing are the main measures recommended.
Apr 17, 2026
The FDA has announced plans to crack down on active pharmaceutical ingredients used in compounded GLP-1 drugs and warned about the risks of these products. The agency has cited counterfeit products, non-FDA-approved ingredients and more than 1,000 adverse event reports tied to compounded semaglutide and tirzepatide.
Apr 11, 2026
Two phase 3 trials found upadacitinib 15 mg significantly improved facial and total repigmentation versus placebo at 48 weeks in nonsegmental vitiligo. The 614-patient studies also showed continued improvement over time and a safety profile consistent with prior use.
Mar 17, 2026
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
Mar 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
Feb 25, 2026
The FDA approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 24, 2026
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
Feb 24, 2026
The FDA has expanded approval of Wakix (pitolisant) to treat cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-controlled substance approved for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 23, 2026
The FDA approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, based on Phase 3 AMPLIFY trial results.
Feb 20, 2026
The FDA has approved a supplemental new drug application for the combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia, supported by Phase 3 AMPLIFY trial data.
Feb 20, 2026
The FDA approved AbbVie's combination of Venclexta and acalabrutinib as the first all-oral, fixed-duration treatment for previously untreated chronic lymphocytic leukemia patients, based on Phase 3 trial data showing 35% reduction in disease progression risk.
Feb 20, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
Feb 18, 2026
The FDA has approved Harmony Biosciences' Wakix (pitolisant) for treating cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 20, 2026
The FDA has approved the combination of Venclexta (venetoclax) plus acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia, based on Phase III AMPLIFY study results.
Feb 18, 2026
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 14, 2026
Clinical studies demonstrate GLP-1 receptor agonists like semaglutide and tirzepatide produce substantial weight loss when combined with lifestyle changes, with patients achieving mean reductions of 14.9% body weight over 68 weeks.
Dec 22, 2025
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
