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125 stories matching this filter · ← front page

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  • Vaisala Oyj discloses executive Girish Agarwal receiving 1,000 shares at no cost
    Vaisala Oyj, a Finnish climate‑measurement technology company listed on Nasdaq Helsinki, filed a regulatory notice on 23 July 2026 regarding an insider transaction. The notice identifies Girish Ag…
    globenewswire health · 2mo agoRegulatoryNeutral↗ source
  • DSV A/S reports manager share transactions in latest company announcement
    DSV A/S issued Company Announcement No. 1171, informing the market of recent share transactions carried out by a company manager. The disclosure is made under Article 19 of EU Regulation 596/2014,…
    globenewswire health · 2mo agoRegulatoryNeutral↗ source
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  • Chairman of Urbo Bank purchases €25,000 of bank's subordinated bonds
    Urbo bankas UAB disclosed that its Chairman of the Board, Marius Arlauskas, acquired the bank's subordinated bonds. The acquisition covered 25 bonds with a total consideration of EUR 25,000 and wa…
    globenewswire health · 2mo agoRegulatoryNeutral↗ source
  • Alm. Brand A/S discloses executive share transactions per EU regulation
    Alm. Brand A/S has issued a regulatory filing that details recent trading activity in its own shares by company executives and their related parties. The disclosure is made under Article 19 of EU…
    globenewswire health · 2mo agoRegulatoryNeutral↗ source
  • Urbo Bank discloses board chair’s purchase of 25 subordinated bonds for €25,000
    Urbo Bank announced that its board chairman and administration head, Marius Arlauskas, bought 25 units of the bank’s subordinated bonds (ISIN LT0000135659). The purchase, amounting to €25,000, was…
    globenewswire health · 2mo agoDealNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 3mo agoRegulatoryNeutral↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 3mo agoRegulatoryNeutral↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA proposes rule to require foreign tobacco makers to register and list products, aiming to curb illegal imports and protect youth
    The U.S. Food and Drug Administration announced on June 26, 2026 a proposed rule intended to strengthen its ability to identify illegal foreign tobacco products, including youth‑appealing e‑cigaret…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
    FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA approves OTC naloxone nasal spray Rextovy, expanding consumer access to overdose treatment
    The FDA announced approval of a new over-the-counter naloxone nasal spray called Rextovy, delivering 4 mg of naloxone hydrochloride for emergency reversal of opioid overdose. The product can be pu…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA grants accelerated approval for Tzield to delay insulin loss in children with newly diagnosed Stage 3 type 1 diabetes
    The U.S. Food and Drug Administration issued an accelerated approval on June 12, 2026 for Tzield (teplizumab) to slow the decline of insulin production in pediatric patients aged 8 to 17 who have r…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
    The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin. This is the first OTC…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA grants emergency use authorization for generic Nitenpyram tablets to treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for generic Nitenpyram tablets to treat New World screwworm infestations in dogs, puppies, cats and kittens that weig…
    fda press · 4mo agoRegulatoryPositive↗ source
  • FDA adds bemotrizinol, first new sunscreen ingredient in 20 years
    The U.S. Food and Drug Administration has approved bemotrizinol as a new active ingredient for over‑the‑counter sunscreens, marking the first addition to the sunscreen monograph since the late 1990…
    fda press · 4mo agoRegulatoryPositive↗ source
  • FDA releases draft guidance to speed cell and gene therapy approvals
    The FDA announced a draft guidance aimed at helping developers bring gene therapies to patients more quickly. It encourages use of publicly available scientific data and existing platform knowledge…
    fda press · 4mo agoRegulatoryNeutral↗ source
  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 4mo agoRegulatoryPositive↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA issues warning letters to eight retailers for selling unauthorized tobacco products that mimic candy and other everyday items
    The U.S. Food and Drug Administration announced on May 20, 2026 that it has sent warning letters to eight retailers for offering unauthorized nicotine pouches and dissolvable tobacco products that…
    fda press · 5mo agoRegulatoryNegative↗ source
  • FDA reopens comment period for BHT and launches post-market chemical safety program
    The U.S. Food and Drug Administration announced two actions as part of its ongoing food chemical safety agenda. The agency will reopen the comment period for the Request for Information on butylat…
    fda press · 5mo agoRegulatoryNeutral↗ source