Industry News

21 November 2024

Syndax announces FDA approval of Revuforj (revumenib)

Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Revuforj revumenib as the first and only menin inhibitor for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene KMT2A translocation in adult and pediatric patients one year and older.

15 November 2024

Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio

Sandoz the global leader in generic and biosimilar medicines, today announced that the European Commission (EC) has granted marketing authorization for Afqlir® (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea®. Afqlir® is indicated to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD), aiming to prevent disease-related blindness.

29 October 2024

Iterum Therapeutics receives USFDA approval of ORLYNVAH (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

Iterum Therapeutics plc announced that the U.S. Food and Drug Administration has approved Iterums new drug application for ORLYNVAH for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

21 October 2024

Alembic Pharmaceuticals announces USFDA final approval for Diltiazem Hydrochloride

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg.

10 October 2024

Amneal and Metsera Announce Strategic Collaboration to Develop and Supply Portfolio of Next-Generation Medicines for Obesity and Metabolic Diseases

Amneal Pharmaceuticals, Inc, a global pharmaceutical company, and Metsera, Inc. , a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced that they have entered into a collaboration agreement to enable the efficient development and large-scale supply of a portfolio of new weight loss medicines globally.

9 October 2024

GSK planning to strengthen vaccination ecosystem and oncology portfolio

There are some big picture changes underway driving GSK's upbeat stance on adult immunization. With a population of about 1.43bn and improving life expectancy in India, the preventive medicine theme is gaining traction, including on the policy front.

4 October 2024

Mankind Pharma to acquire Bharat Serums from Advent International for Rs 13,630 cr

Mankind Pharma Limited has entered into a definitive agreement to acquire a 100% stake in Bharat Serums and Vaccines Limited from Advent International, one of the world’s largest and most experienced private equity investors, for an enterprise value of approx. INR 13,630 Crores, subject to closing related adjustments, the company said in a statement on exchanges.

4 October 2024

Dr. Reddy’s Lab signs agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

Dr. Reddy’s Laboratories Ltd. announced that it has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialisation of the drug, Lenacapavir, in India and 120 other countries.

27 September 2024

FDA approves Drug with New Mechanism of Action for Treatment of Schizophrenia

The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.

27 September 2024

Torrent Pharma refutes claims of Shelcal 500 allegedly failing CDSCO quality test

Recent articles have been issued in media with reference to the Central Drugs Standard Control Organization East Zone, Kolkata report referring to one batch sample of Product Shelcal 500, amongst other drugs marketed by various pharmaceutical companies, allegedly being non-standard quality.

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Syndax announces FDA approval of Revuforj (revumenib)

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