Eli Lilly and Company (NYSE: LLY) has announced that the U.S. Food and Drug Administration (FDA) plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial,…
Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on seralutinib for pulmonary arterial hypertension (PAH) treatment, reported its financials for Q4 and full-year 2023 and updated on business progress. Faheem Hasnain, Chairman, Co-Founder, and CEO, stated, “We initiated…
Vivani Medical, Inc. (Nasdaq: VANI), a pioneering biopharmaceutical company in the preclinical stage, has recently announced a significant move towards advancing its innovative long-term drug implants. In a registered direct offering, the company has entered into a securities purchase agreement…
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that Shionogi and Osaka University (Location: Suita, Osaka, President: Shojiro Nishio) have established a joint research laboratory (research lab’s name: Joint Research Laboratory…
AbbVie (NYSE: ABBV) announces today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) concerning epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody. This treatment targets adult patients with relapsed…
Bristol Myers Squibb (NYSE: BMY) has confirmed the conclusion of its tender offer, initially announced, to acquire all outstanding shares of RayzeBio, Inc. (Nasdaq: RYZB) common stock at a price of $62.50 per share in cash, totaling approximately $4.1 billion.…
The U.S. Food and Drug Administration (FDA) has given priority review status to the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab), marking its sixth potential indication. This review targets its use as an add-on maintenance treatment for specific adult…
Merck (NYSE: MRK), also known as MSD outside of the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval…
Today, Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has officially launched the application process for its 2024 BOTOX® Cosmetic grant program, aimed at supporting women entrepreneurs. Following a successful partnership with IFundWomen in 2023, this year marks the second…
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company dedicated to enhancing the well-being of individuals with severe autoimmune conditions, has announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA)…
Leading global pharmaceutical company Lupin Limited (Lupin) has announced the introduction of Ganirelix Acetate Injection, 250 mcg mL, Single-Dose Prefilled Syringe, following approval from the United States Food and Drug Administration (U.S. FDA). This generic equivalent to the reference listed…
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) revealed today that it has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for its experimental drug olezarsen. This designation is specifically for the treatment of familial chylomicronemia syndrome (FCS), a…
