Pharmaceuticals and Drug Development Access Denied Access Denied You don’t have permission to access ” on this server. Reference #18.1d6d3e17.1746004019.104ab9a1 Written by Admin April 30, 2025April 30, 2025 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease LEXINGTON, Mass.–(BUSINESS WIRE)–Apr. 3, 2025– Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today… Written by Admin April 24, 2025April 24, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised this new indication for Anastrozole, a hormone treatment used for breast cancer in post-menopausal women. Anastrozole was already authorised for use in the treatment of breast cancer in post-menopausal women and has been used off-label for prevention. Today’s announcement confirms the authorisation for […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom April 12, 2025April 12, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development FDA Issues Complete Response Letter for Etripamil for PSVT MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug… Written by Admin March 31, 2025March 31, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development BugBiome wins Discovery Spark life science programme Sandwich, UK, 6th December 2023 / Discovery Park / BugBiome was announced as the winner of the Discovery Spark life science business support programme at the GIANT Health Healthcare Investment Show on 5th December. BugBiome will be awarded a business support package worth over £100,000, including one year of free lab space at Discovery Park […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom March 19, 2025March 19, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) London, UK — 03 March 2025 — GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications. The proposed indications are… Written by Admin March 7, 2025March 7, 2025 Saving Bookmark this article Bookmarked
Skull study shows Chicago’s rodents are rapidly evolving In general, evolution is a long, slow process of tiny changes passed down over generations, resulting in new adaptations and even new species over thousands or millions of years. But when living things are faced with dramatic shifts in the world around them, they sometimes rapidly adapt to better survive. Scientists recently found an example […] Written by Admin June 29, 2025June 29, 2025 Saving Bookmark this article Bookmarked
EU Commissioner Várhelyi revives Biotech Act for 2025 In a panel discussion at Medicines for Europe Annual Conference, EU Health Commissioner Olivér Várhelyi made a surprise announcement that the Commission will adopt the EU Biotech Act by the end of this year, citing growing “global challenges”. According to the EU Commission’s work programme, the legislation was initially scheduled for adoption in Q3 2025, […] Written by Thomas Gabrielczyk June 28, 2025June 28, 2025 Saving Bookmark this article Bookmarked
Skull study shows Chicago’s rodents are rapidly evolving In general, evolution is a long, slow process of tiny changes passed down over generations, resulting in new adaptations and even new species over thousands or millions of years. But when living things are faced with dramatic shifts in the world around them, they sometimes rapidly adapt to better survive. Scientists recently found an example […] Written by Admin June 29, 2025June 29, 2025 Saving Bookmark this article Bookmarked
EU Commissioner Várhelyi revives Biotech Act for 2025 In a panel discussion at Medicines for Europe Annual Conference, EU Health Commissioner Olivér Várhelyi made a surprise announcement that the Commission will adopt the EU Biotech Act by the end of this year, citing growing “global challenges”. According to the EU Commission’s work programme, the legislation was initially scheduled for adoption in Q3 2025, […] Written by Thomas Gabrielczyk June 28, 2025June 28, 2025 Saving Bookmark this article Bookmarked
These 545-million-year-old fossil trails just rewrote the story of evolution The Cambrian explosion was an extraordinary phenomenon in the evolution of life on the planet that led to the emergence of many animal phyla and the diversification of species. During this period, some 530 million years ago, most of the basic body plans of organisms that have survived to the present day emerged. However, this […] Written by Admin June 27, 2025June 27, 2025 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked
