INLEXZO FDA approval brings new hope for BCG-unresponsive bladder cancer, offering a bladder-sparing, high-response alternative to surgery.

Teva’s long-acting subcutaneous formulation of Johnson and Johnson’s (J&J) Risperdal is already approved for schizophrenia.

FDA approves suzetrigine (VX-548), for acute pain relief—the first new non-opioid analgesic in over 20 years.

ScreenPoint Medical presents groundbreaking updates to its Breast AI, Transpara, recently approved by the FDA, enhancing cancer detection capabilities at RSNA 2024.

Emma Walmsley and her GSK CEO successor, Luke Miels, are safeguarding the British pharma’s 40 billion-pound-sterling sales projection for 2031 on the back of a strong quarter. | Emma Walmsley and her ...

In a groundbreaking development, Neurocrine Biosciences, Inc. has announced the FDA approval of CRENESSITY™ (crinecerfont), a first-in-class therapy for managing classic congenital adrenal hyperplasia...

Celltrion, a South Korean biopharmaceutical firm, received FDA approval for two new biosimilars, Stoboclo and Osenvelt, for bone disease treatment in the U.S. The company aims to expand its biosimilar...

Checkpoint Therapeutics, Inc. has officially announced a groundbreaking achievement with the U.

Almost half of all novel medications approved by the U.S. FDA are orphan drugs. Below is the list of important regulatory dates for all orphan drugs for 2025.

Johnson & Johnson has just achieved a major breakthrough in the mental health space, with the approval of SPRAVATO® (esketamine) nasal spray as the first and only monotherapy for adults suffering from...

FDA grants 510(k) clearance for Hologic’s Aptima SARS-CoV-2 assay, which uses the Panther system for high-throughput RNA detection.

Investing.com -- Viatris Inc (NASDAQ:VTRS) stock rose 2.6% following the U.S. Food and Drug Administration’s approval of the company’s Iron Sucrose Injection, USP, the first generic version of Venofer® Injection. The intravenous iron replacement product is used to treat iron deficiency anemia in adult and pediatric patients with chronic kidney disease. The medication will be available in single dose vials in three strengths: 50 mg/2.5mL, 100mg/5mL, and 200mg/10mL. The FDA granted Viatris a competitive generic therapy designation for the 100 mg/5 mL and 200 mg/10 mL strengths, which provides expedited review and eligibility for 180 days of market exclusivity upon commercial launch. "The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris’ advanced technical and manufacturing capabilities," said Philippe Martin, Viatris Chief R&D Officer. The company developed the complex injectable product in-house after working closely with the FDA for several years. Viatris noted that its pipeline includes additional complex injectables across multiple therapeutic areas, including ferric carboxymaltose injection, another iron replacement product. According to IQVIA data cited by Viatris, Venofer® had annual sales of approximately $515 million in the U.S. as of June 30, 2025. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab-gcpt for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received...

The drug is part of an expanding cardio-renal-metabolic care portfolio, is approved for CKD associated with type 2 diabetes.

Capricor Therapeutics (CAPR), a clinical-stage biotechnology company, announced financial results for the first quarter of 2025 and shared a regulatory update o

The US regulatory agency approves Sanofi’s Wayrilz as the first BTK inhibitor for treating persistent or chronic immune thrombocytopenia.

The FDA accepted an NDA for vepdegestrant in ER-positive, HER2-negative advanced breast cancer harboring ESR1 mutations after prior endocrine therapy.