U.S. FDA

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• U.S. FDA classifies recall of Philips' respiratory devices as most serious

  The U.S. health regulator said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination. The company's ventilators provide breathing assistance to both pediatric and adult patients.

  

• Olympus says fixing issues raised by U.S. FDA about facilities in Japan

  The U.S. Food and Drug Administration (FDA) said on Monday it had issued warning letters to Olympus' units pertaining to a category of devices known as endoscopes, citing violations at its facilities. Olympus said it was making changes to the quality systems at its facilities.

  

• U.S. FDA approves Mirati's lung cancer drug

  Adagrasib, an oral drug, is designed to target a mutated form of a gene known as KRAS that occurs in about 13 per cent of non-small cell lung cancers (NSCLC), the most common form of the disease, and less frequently in some other solid tumors. Mirati said the drug will be sold under the brand name Krazati at a price of $19,750 for a 200 milligram tablet/180 count bottle.

  

• Bubs Australia seeks permanent market access from U.S. FDA

  Bubs said it had lodged a letter of intent with the U.S. FDA for permanent market access to October 2025 and beyond, adding that the FDA will issue a letter of acknowledgement in response.

  

• U.S. FDA puts Avidity's muscle disorder drug trial on partial hold

  California-based Avidity did not disclose any details about the event, but said it was working closely with the health regulator and a trial investigator to assess the cause, and taking steps to resolve the hold as quickly as possible.

  

• U.S. FDA advisers recommend change to COVID vaccine composition for fall

  FDA scientists at the meeting suggested they preferred vaccines that will target the BA.4 and BA.5 Omicron subvariants that are currently dominant rather than the BA.1 Omicron variant that led to a massive surge in infections last winter.

  

• Glenmark receives ANDA approval for topical treatment of plaque psoriasis in adults

  Calcipotriol/betamethasone dipropionate foam (Enstilar®) is a fixed-dose combination foam formulation containing a synthetic vitamin D3 analogue and a synthetic corticosteroid that is used to treat plaque psoriasis in adults.

  

• U.S. FDA approves Marinus Pharma's lead drug to treat genetic disorder

  The oral drug, which will be sold under the brand name Ztalmy, is intended specifically for treatment of seizures associated with CDKL5 deficiency disorder, a rare genetic epilepsy.

  

• U.S. FDA limits use of Regeneron, Lilly COVID-19 antibody treatments

  The Food and Drug Administration (FDA) said the treatments are currently not cleared for use in any U.S. states or territories, but may be authorized in certain regions if they work against potential new variants.

  

• U.S. FDA approves drugs from AbbVie, Pfizer to treat eczema

  AbbVie's Rinvoq and Pfizer's Cibinqo have been approved to treat moderate-to-severe atopic dermatitis, or eczema, in patients who do not respond to previous treatment or when use of other treatments is not recommended.

  

• U.S. FDA amends J&J vaccine fact sheet to include rare bleeding risk

  The symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the FDA said.