Drug Approval | 17 July 2025
Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Celecoxib is a nonsteroidal anti-inflammatory drug
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The audit has been concluded with no major observations
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Granules India receives 1 observation from USFDA for Chantilly facility
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
The inspection concluded with zero Form 483 observations
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
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