Skip to main content

Industry News

Join WhatsApp Channel 

Regulatory Affairs Courses
  • EU Panel Backs Roche’s Susvimo, Opening New Era for Continuous AMD Treatment

    Roche has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Susvimo® (ranibizumab) for the treatment of neovascular age-related macular degeneration (nAMD). If the European Commission grants final approval, Susvimo will become the first continuous drug-delivery treatment for nAMD in the European Union.

  • US FDA Warns Almon Healthcare Over Serious API GMP Lapses

    The U.S. Food and Drug Administration (US FDA) has issued a Warning Letter to Almon Healthcare Private Limited, Ahmedabad, Gujarat, after identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations at its active pharmaceutical ingredient (API) manufacturing facility during an inspection conducted from February 9–13, 2026. The warning letter was issued on July 13, 2026.

  • Novo Nordisk Files Lawsuit Against Eli Lilly Over GLP-1 Drug Advertisements

    Novo Nordisk has announced that it has filed a lawsuit against Eli Lilly and Company in the United States, alleging that Lilly's advertising campaigns for its GLP-1 medicines are misleading and do not present complete scientific information.

  • Sanofi Publicly Reprimanded by UK Pharma Watchdog After Pfizer Complaint

    Global pharmaceutical company Sanofi has received a Public Reprimand from the Prescription Medicines Code of Practice Authority (PMCPA) after a complaint was filed by Pfizer.

    The PMCPA investigated the case (CASE/0689/08/25) and found that Sanofi had breached several rules of the 2024 ABPI Code of Practice, which sets standards for how pharmaceutical companies should promote their medicines in the UK.

  • USFDA Issues One Observation After Routine cGMP Inspection at Cipla's InvaGen Facility in New York

    Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) conducted a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of its wholly owned subsidiary, InvaGen Pharmaceuticals Inc., located in Central Islip, Long Island, New York, USA.

    The inspection was carried out from July 13 to July 17, 2026 (EDT) as part of the USFDA's routine regulatory oversight of pharmaceutical manufacturing facilities.

  • Alembic Partner NATCO Gets USFDA Tentative Approval Olaparib Tablets

    Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

    Alembic Pharmaceuticals Limited (Alembic) today announced that its Partner NATCO Pharma Limited (NATCO) has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olaparib Tablets, 100 mg and 150 mg. 

  • India Approves First Dengue Vaccine : DCGI Clears Takeda's QDENGA for People Aged 4-60 Years

    In a landmark development for dengue prevention, the Drug Controller General of India (DCGI) has granted market authorization to Takeda Biopharmaceuticals India's QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]), making it the first dengue vaccine approved in India. The vaccine is approved for the prevention of dengue in individuals 4 to 60 years of age and can be administered regardless of prior dengue infection, eliminating the need for pre-vaccination screening.

  • Johnson & Johnson Reports Strong Q2 2026 Results, Raises Full-Year Outlook
    Johnson & Johnson has reported strong financial results for the second quarter of 2026, driven by continued growth across its Innovative Medicine and MedTech businesses.
  • FDA Issues Form 483 to Catalent Indiana Over Sterile Drug Manufacturing Concerns
    The U.S. Food and Drug Administration, FDA has issued a Form FDA 483 to Catalent Indiana LLC. The inspection identified multiple observations related to quality systems, contamination control, investigations, and sterile manufacturing practices at the facility.
  • European Commission Approves Novo Nordisk's Oral Wegovy, Marking New Era in Obesity Treatment

    Novo Nordisk has announced that the European Commission (EC) has approved Wegovy® (semaglutide) tablets for chronic weight management, making it the first oral GLP-1 receptor agonist authorized in the European Union for the treatment of obesity and overweight. The approval also includes a single, ready-to-use 7.2 mg Wegovy injection pen, providing healthcare professionals and patients with additional treatment options.

Subscribe to Industry News