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  • Dr. Reddy’s issues voluntary recall of Sapropterin Dihydrochloride Powder

    Dr. Reddys Lab announced that it is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.
  • Zydus launches Mirabegron Extended-Release Tablets in the US
    Zydus Lifesciences launches Mirabegron Extended-Release Tablets, 25 mg in the US market. The company had earlier received final approval from the United States Food and Drug Administration USFDA to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg. Mirabegron is indicated for the treatment of overactive bladder OAB with symptoms of urge urinary incontinence, urgency and urinary frequency
  • Nestle accused of double standards over added sugar in baby products in India

    Nestle, promoted in low and middle-income countries as healthy and key to supporting young children’s development, contains high levels of added sugar. In Europe and UK such products are sold with no added sugar. These are the main findings of a new investigation by Public Eye and the International Baby Food Action Network (IBFAN), which shed light on Nestle's hypocrisy and the deceptive marketing strategies deployed by the Swiss food giant.

  • Novartis Kesimpta six-year efficacy data show benefits in MS

    Novartis today announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta® (ofatumumab) treatment for up to six years in recently diagnosed – defined as starting treatment within three years of initial diagnosis – treatment-naïve people living with relapsing multiple sclerosis (RMS).

  • GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by USFDA

    GSK plc announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025.

  • Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

    Strides Pharma Science Limited (Strides) today announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Fluoxetine Tabs 10 mg and 20 mg, from the United States Food & Drug Administration (USFDA).

    The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac® Tablets of Eli Lilly.

  • Dr. Reddy’s launches drug-free migraine management device Nerivio in Europe following successful launch in India

    Dr. Reddy’s Laboratories Ltd a global pharmaceutical company, announced the launch of the drug-free non-invasive migraine management wearable device Nerivio® in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio® is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe.

  • Pfizer announces positive Top-Line Results from Phase 3 Study of ABRYSVO in Adults Aged 18 to 59 at Increased Risk for RSV Disease

    Pfizer Inc announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness),evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).

  • Dr. Reddy to distribute vaccines brands of Sanofi Healthcare

    Dr. Reddy’s Laboratories Ltd a global pharmaceutical company, announced that it has entered into an exclusive partnership with Sanofi Healthcare India Private Limited to promote and distribute their vaccine brands across private markets in India.

  • Basilea announces USFDA approval of antibiotic ceftobiprole medocaril for three indications

    Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that the US Food and Drug Administration (FDA) approved ZEVTERA® (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 mo

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