EKTERLY to be added to the Orphan Register and awarded 10 years of market exclusivity CAMBRIDGE, Mass. & SALISBURY, England / Jul 15, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment...Read more
The first approval worldwide for elinzanetant, under the brand name LynkuetTM (Lynkuet®* in the UK), for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause is based on results from the three pivotal trials in the OASIS Phase III clinical development program1 / Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) and has...Read more
ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping eliminate cancer Already approved in the U.S. and designated as a Breakthrough Therapy by the FDA, this marks ANKTIVA’s first marketing approval outside the U.S. ANKTIVA plus BCG offers a new option for eligible patients among the 16,400 to 18,000 people diagnosed with NMIBC in the...Read more
The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalization (CVH)) durably separated relative to placeboA 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30A 50%...Read more
UK Medicines and Healthcare products Regulatory Agency (MHRA) authorisation based on FELIX clinical trial of obecabtagene autoleucel in adult patients with r/r B-ALL1 AUCATZYL® licensed from MHRA under ‘conditional marketing authorisation’, meaning that the MHRA will review new efficacy and safety information at least once every year1 LONDON, April 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early...Read more
BOULDER, CO / ACCESS Newswire / April 22, 2025 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced the registration of its hypochlorous acid-based acne...Read more
REYKJAVIK, Iceland, PISCATAWAY, N.J. and LONDON, March 26, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus...Read more
BOULDER, CO / ACCESS Newswire / March 10, 2025 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced the registration of its manufacturing facility and five...Read more
mRESVIA® is Moderna's second approved product in the UK CAMBRIDGE, MA / ACCESS Newswire / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in...Read more
CULVER CITY, Calif. / Feb 13, 2025 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin assessing the marketing authorization application (MAA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with bacillus...Read more
MELBOURNE, Australia, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection). Illuccix is indicated in the UK...Read more
ATLANTA, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible in-office therapeutic and diagnostic products, announces the receipt of the Medicines & Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed® Intratubal Insemination product for female infertility...Read more
Company on track to initiate ELEVATE-44-201 in Q2 2025 ENTR-601-44 regulatory filings submitted in additional geographies including the U.S. and EU, with regulatory discussions ongoing BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced it had received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics...Read more
Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to European Medicines Agency (EMA) in December 2024 and anticipated acceptance of application in 2025 Marketing authorization application for BCG Unresponsive NMIBC CIS submitted to United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024 and anticipated acceptance...Read more
REC-3565 is a potential best-in-class MALT1 inhibitor for multiple hematology indications, designed to reduce the risk of hyperbilirubinemia, a common side effect of other MALT1 inhibitors REC-4539, a potential best-in-class LSD1 inhibitor, is the first designed to be reversible and CNS penetrant for small-cell lung cancer Salt Lake City, UT, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage...Read more
IMDYLLTRA® is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy, including platinum-based chemotherapy1 Lung cancer is the third most common cancer in the UK, with more than 49,000 cases diagnosed in the UK between 2017 and 20192 Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancers3 In...Read more
Canada and United Kingdom represent two of the largest markets within the ALK portfolio with plans to expand filings of neffy (epinephrine nasal spray) 2 mg in other key global regions SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to...Read more
Innovation Passport Designation Aims to Accelerate Time to Market and Facilitate Patient Access to Innovative Medicines NEW YORK / Dec 05, 2024 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that MM120 ODT, a pharmaceutically optimized form of lysergide...Read more
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity...Read more
Great Britain is the third major market where donanemab has received approval Donanemab was first approved in the United States in July 2024 and then approved in Japan in September 2024 INDIANAPOLIS, Oct. 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion...Read more
VIENNA, Va. / Sep 04, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate...Read more
Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines At present, the JN.1 group of subvariants remain dominant in the UK The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today...Read more
In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd....Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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