• FDA approves Lilly and Incytes OLUMIANT
    14 June 2022

    FDA approves Lilly and Incytes OLUMIANT (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areata

    Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.  The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day.

  • 10 June 2022
    Alembic Pharmaceuticals receives USFDA Tentative approval for Dasatinib Tablets

    Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company (BMS).

  • 28 May 2022
    Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA

    Amneal Pharmaceuticals, Inc.announced that the U.S. Food and Drug Administration has approved the Company’s Biologics License Applicationfor pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.

  • 26 May 2022
    Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

    Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to market Pemetrexed for Injection, in the strengths of 100 mg/vial,500 mg/vial, and 1000 mg/vial Single-Dose Vials (USRLD: Alimta). Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma.

  • 11 May 2022
    USFDA issues 6 observations after inspection of Aurobindo Pharma Jedcherla plant

    Aurobindo Pharma receives 6 observations after inspection of Aurobindo Pharma Jedcherla plant.

    The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from 2nd to 10th May 2022.

  • 28 April 2022
    Systemic sclerosis drug of Gesynta Pharma gets Orphan Drug Designation by USFDA

    Gesynta Pharma AB announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud’s phenomenon secondary to systemic sclerosis.

  • 22 April 2022
    Lupin Receives Tentative Approval from U.S. FDA for Tenofovir Alafenamide Tablets

    Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

  • 6 April 2022
    FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)

    Novartis announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million.

  • 30 March 2022
    FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

    The U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death.

  • 24 March 2022
    Indoco Remedies receives USFDA nod for Lacosamide Tablets

    Indoco Remedies Ltd. announces final approval from the United States Food and Drug Administration (USFDA) for Lacosamide Tablets USP 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets of UCB, Inc.

    Lacosamide Tablets are indicated for the prevention and control of seizures. It is an anticonvulsant / antiepileptic drug.

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