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  • Ohio launches $30M Life Science Training Center to boost biomanufacturing workforce
    Ohio’s JobsOhio agency and the Ohio Life Sciences Association announced a public-private training center backed by up to $30 million. The center is intended to create a statewide pipeline of operat…
    Fierce Biotech · 4mo agoPositive↗ 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 · 4mo agoRegulatoryPositive↗ source
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  • 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoRegulatoryPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 4mo agoNeutral↗ source
  • Biopharma manufacturers turn to flexible, modular facilities to meet diverse therapy demands
    Biopharma development is increasingly focused on specialized and personalized treatments such as cell and gene therapies, antibody-drug conjugates and monoclonal antibodies. At the same time, the m…
    Fierce Biotech · 4mo agoPositive↗ 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 6mo agoRegulatoryNeutral↗ source
  • Biotech layoff tracker 2026 shows Clinuvel cuts 20% staff, Novartis sheds 322 US jobs
    Fierce Biotech released its fifth annual layoff tracker for 2026, noting that workforce reductions continue to rise in the sector after a year of increasing cuts. The July update lists two compani…
    Fierce Biotech · 10mo agoLayoffsNegative↗ source
  • Biotech fundraising tracker reports $70M Series C for Ratio Therapeutics and $130M Series B for Crystalys Therapeutics
    The Fierce Biotech Fundraising Tracker continues to log only large venture capital rounds, focusing on deals of $50 million or more. Ratio Therapeutics secured a $70 million Series C, backed by in…
    Fierce Biotech · 10mo agoDealNeutral↗ source