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  • Novo Nordisk announced results from the kidney outcomes trial FLOW

    Novo Nordisk announced the headline results from the kidney outcomes trial FLOW. The announcement follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD).

  • Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer

    Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

  • Bristol Myers Squibb Completes Acquisition of RayzeBio

    Bristol Myers Squibb announced today that it has successfully completed its acquisition of RayzeBio, Inc. With the completion of the acquisition, RayzeBio shares have ceased trading on the NASDAQ Global Market and RayzeBio is now a wholly owned subsidiary of Bristol Myers Squibb.

  • Piramal Pharma Lexington facility gets 2 USFDA observations

    US FDA conducted a Pre-Approval Inspection (PAI) inspection of Piramal Pharma Limited's Lexington (USA) facility from 20 th February, 2024 to 23rd February, 2024 for one of the product expected to be manufactured at this facility.

    On conclusion of the inspection, a Form-483 was issued with 2 observations. The observations does not pose any risk to site’s compliance standards or its business continuity.

  • Sclerosis medicine from Biogen backed by EU

    Biogen Inc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

  • Bristol Myers Squibb announces acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy

    Bristol Myers Squibb announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024.

  • AstraZeneca Pharma receives permission for Palivizumab

    AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Palivizumab (Synagis) solution for injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route).

  • Johnson & Johnson offers USD 8.9 Bn to settle talc suits

    Johnson & Johnson has reached a deal in the long-running lawsuit against its talc-based products. Thousands of people have sued the company over the past decade, claiming the products - including its iconic baby powder - caused cancer.

  • Granules Consumer Health Inc., inaugurates its Packaging Facility in the U.S.

    Granules India inaugurated and launched its packaging facility through its Granules Consumer Health (GCH) step-down subsidiary which is located in Manassas, Virginia, US. The facility is over 79,000 square feet and is equipped with packaging lines and clean rooms to package and ship prescription and over-the-counter products across the U.S. market. The facility recently received US FDA approval with zero 483 observations.

  • Granules India Limited Received ANDA approval for Losartan Potassium Tablets

    Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.

    It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).

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