USFDA

30 December 2024

Halozyme Announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE

Halozyme Therapeutics, Inc announced that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme's ENHANZE® drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

25 December 2024

FDA approves Zepbound as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity

Eli Lilly and Company announced the U.S. Food and Drug Administration approved Zepbound tirzepatide as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea OSA and obesity.

19 December 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Zydus Life sciences Limited has received final approval from the United States Food and Drug Administration to manufacture Lidocaine and Prilocaine Cream USP.

19 December 2024

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

The U.S. Food and Drug Administration approved Ryoncil remestemcel-L-rknd, an allogeneic donor bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease SR-aGVHD in pediatric patients 2 months of age and older.

19 December 2024

Granules India Limited announces FDA approval for ADHD Treatment

Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. , has received approval from the U.S. Food & Drug Administration for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Chewable Tablets.

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.

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.

29 September 2024

U.S Food and Drug Administration looking for Pharmacologist / Toxicologist

As a Pharmacologist, Toxicologist, the incumbent is responsible for reviewing and evaluating drug applications and communicating conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology, toxicology or clinical drug review divisions located within OND.

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.

23 September 2024

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

The U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age.

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Halozyme Announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE

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