Articles

  • 3 weeks ago | fiercehealthcare.com | Kevin Dunleavy

  • 3 weeks ago | fiercepharma.com | Kevin Dunleavy

    Days after FDA Commissioner Marty Makary said that the agency planned to review the safety of abortion pill mifepristone, attorneys general from four pro-abortion states have fired back, filing  (PDF) a petition asking the U.S. regulator to lift restrictions on the treatment.

  • 3 weeks ago | fiercepharma.com | Kevin Dunleavy

    Drugmakers and contract manufacturers are responding to the booming demand for antibody-drug conjugates, with multiple expansion projects announced in recent years to support the targeted cancer treatments.

  • 3 weeks ago | fiercepharma.com | Kevin Dunleavy

    Amneal Pharmaceuticals is recalling three lots of sulfamethoxazole/trimethoprim tablets because of microbial contamination that caused black spots to appear on the medication, according to a report from a customer. The New Jersey-based generics manufacturer has issued a U.S. recall of three lots of the 400-mg/80-mg tablets that may be contaminated with Aspergillus, a fungus that can cause life-threatening infections, especially for those with underlying immunosuppressive conditions, the FDA said.

  • 3 weeks ago | fiercepharma.com | Kevin Dunleavy

    Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC.

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Kevin Dunleavy
Kevin Dunleavy @KDunleavy
5 Feb 25

RT @46brooklyndata: Amid more drug-price scrutiny, biopharma companies largely keep their January hikes in check @KDunleavy https://t.co/no…

Kevin Dunleavy
Kevin Dunleavy @KDunleavy
7 Oct 24

RT @FiercePharma: Off the scrapheap of discarded drugs and on its way to becoming the most highly anticipated approval of 2024, Bristol Mye…

Kevin Dunleavy
Kevin Dunleavy @KDunleavy
26 Jun 24

RT @FiercePharma: Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's https://t.co/V1RQCd1fD8