Regulatory

Hong Kong-based Guangdong Hengrui Pharmaceuticals’s parent company Jiangsu Hengrui Pharmaceuticals announced that Guangdong Hengrui has received approval from the Chinese National Medical Products Administration (NMPA) for a clinical trial of its HRS-9821 DPI, which the… Read more . . .

Evoke Pharma announced that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for a continuation of US Patent No. 11,517,545 (“Treatment of Moderate and Severe Gastroparesis”), which was issued… Read more . . .

According to Theravance Biopharma, a marketing application submitted to the Chinese National Medical Products Administration (NMPA) by Viatris for Yupelri revefenacin inhalation solution for the treatment of COPD has been approved. In November 2023, Theravance and Viatris announced… Read more . . .

GH Research announced that it has submitted its response to a clinical hold of an IND for the company’s GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. The FDA cited “Insufficient information to… Read more . . .

Milestone Pharmaceuticals says that it completed a Type A meeting with the FDA and subsequently submitted its response to the agency’s complete response letter regarding Milestone’s NDA for Cardamyst etripamil nasal spray for the treatment of… Read more . . .

According to Savara, the FDA has issued an RTF letter in response to the company’s BLA for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), citing insufficient CMC data. Savara completed… Read more . . .

At the end of March 2025, the FDA accepted Liquidia Corporations’s resubmitted NDA for Yutrepia dry powder treprostinil for inhalation for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung… Read more . . .

According to Ritedose Pharmaceuticals, the FDA has approved an ANDA for the company’s generic albuterol sulfate inhalation solution, 0.5%. In April 2023, Ritedose announced that it had begun manufacturing 5 mg/ml albuterol sulfate inhalation solution… Read more . . .

Ritedose Pharmaceuticals has announced that the FDA approved the transfer of an ANDA for formoterol fumarate inhalation solution to Ritedose in April 2025. The company says that it expects to start shipping formoterol fumarate inhalation solution… Read more . . .