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Clinical courses

  • 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

  • Vanda Pharmaceuticals' Fanapt receives USFDA approval for the Acute Treatment of Bipolar I Disorder

    Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt® is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

  • Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

    Genmab A/S and ProfoundBio, Inc. announced  that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. ProfoundBio is a privately-owned clinical-stage biotechnology company developing next-generation ADCs and ADC technologies for the treatment of certain cancers, including ovarian cancer and other FRα-expressing solid tumors. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses). 

  • Abbott receives FDA Approval for TriClip

    Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks.

  • BMS medicine for Crohns disease fails in clinical trial

    Bristol Myers Squibb announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12.

  • FDA approves Merck’s WINREVAIR

    Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. WINREVAIR was previously granted Breakthrough Therapy Designation by the FDA.

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