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The FDA is expected to make a decision on approval by June 19, 2020. “In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared

DSM developed and patented a method to produce a highly pure form of the API. Included in the acquisition are patents, trademarks, trade secret manufacturing processes, analytical methods,

The breakthrough therapy status enables Padcev plus Keytruda combination to treat patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in

The approval from the European Commission (EC) makes VYNDAQEL the first and only treatment for patients with ATTR-CM in the European Union (EU). Considered to be a rare,

The submitted applications are based on pharmacokinetic modeling and simulation data presented at the 2018 ASCO Annual Meeting. These data supported the European Commission approval of 400 mg

Data supporting these Fast Track designations were based on an open-label, multicenter Phase 1 clinical trial of ALX148 in combination with pembrolizumab or trastuzumab. “FDA’s decision to grant

The company will invest around $109m to develop the 135,000ft² gene therapy manufacturing facility. North Carolina Governor Roy Cooper said: “With our powerhouse research centres and highly-skilled workforce,

As per the new drug application (NDA) for lurbinectedin, which has been accepted for filing by the regulator, the two companies are seeking accelerated approval for its use

With the FDA’s approval, Voltaren Arthritis Pain becomes the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States.