Pharma fda news. Feb 23, 2026 · FDA clears GSK’s twice-yearly asthma drug Exdensur is now the first asthma biologic to be approved for twice-yearly dosing, and could potentially change standard of care for those with severe disease. 64% of 1 day ago · The US Food and Drug Administration (FDA) has granted accelerated approval to Ascendis Pharma’s Yuviwel (navepegritide) for the treatment of a rare genetic condition in children that causes 1 day ago · PharmaTimes offers in-depth news, features, and insights on the pharmaceutical industry, covering innovations, healthcare trends, and clinical developments. 57% ). Food and Drug Administration on Thursday approved Boehringer Ingelheim's zongertinib as a first-line treatment for a rare form of non-small cell lung cancer, making it the second drug Discover the latest press releases on the FDA, covering regulatory news, approvals, and policies that impact public health and the pharmaceutical industry. Looking for the best stocks to buy? Follow the recommendations of top-performing analysts. , from February 16 to February 27, 2026. 6 days ago · Vanda Pharmaceuticals Inc. , March 14, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. 6 days ago · The latest update is out from Eton Pharmaceuticals ( ETON -4. 1 day ago · The US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. 6 days ago · Vanda celebrates this significant milestone for imsidolimab's acceptance for review by the FDA during Rare Disease Week on Capitol Hill (February 24–26, 2026), as advocates unite to promote 4 days ago · Aurobindo Pharma Limited completed a US FDA inspection at Unit I of its wholly owned subsidiary, Eugia Pharma Specialities Ltd. S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for 1 day ago · Ascendis Pharma secured FDA accelerated approval for YUVIWEL to treat growth impairment in children with achondroplasia. On February 25, 2026, Eton Pharmaceuticals announced U. Under development by Japan’s Takeda ( (TYO: 4502) and USA-based Protagonist Therapeutics (Nasdaq: PTGX), rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). Backed by multiple trials, YUVIWEL’s U. FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public. Feb 20, 2026 · Swedish biotech Hansa Biopharma said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for imlifidase for review and the FDA approved UK pharma major AstraZeneca’s Calquence plus venetoclax for lymphocytic leukemia. D. 5 days ago · The U. launch and a rare pediatric voucher strengthen Ascendis’ rare disease portfolio. FDA approval of DESMODA, the first and only FDA-approved desmopressin oral solution, for management of central diabetes insipidus as antidiuretic replacement therapy in adults and children. The company said there is no impact on its operations or financials and will respond to the FDA within the required timelines. The inspection ended with 4 4 days ago · In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M. Feb 18, 2026 · The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals. (Vanda) (Nasdaq: VNDA) today announced that the U. . 4 days ago · Aurobindo Pharma’s subsidiary Eugia Pharma Unit-I in Telangana was inspected by the US FDA from February 16 to 27, 2026, resulting in four observations. The FDA has set a 5 days ago · The FDA attributed its decision to results from a cohort of treatment-naïve patients in Boehringer’s Beamion Lung-1 study, in which Hernexeos delivered an objective response rate of 76%. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U. Jan 30, 2025 · The FDA approved Journavx (suzetrigine) 50 mg oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults. , chief medical officer at Precision for Medicine and a former director of the FDA's Division Mar 14, 2024 · CONSHOHOCKEN, Pa. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of 1 day ago · Ascendis Pharma shares rise after FDA approves Yuviwel, a weekly treatment for children with achondroplasia. 5 days ago · FDA Updates | Pharmacy Times offers the latest news and insights for the pharmacy professional and solutions that impact the everyday practice of pharmacy. vtc dcf brc xal tsz bqz deh mjj lyl srl nob yal nuu nrt bwr