Generic drugs are medications that have been approved by the FDA as equivalent to brand-name drugs in terms of safety, efficacy, and quality.

Hsp90 inhibitors are substances that inhibit the activity of the Hsp90 heat shock protein. They have therapeutic benefit in treating various types of malignancies, as Hsp90 stabilizes a variety of proteins required for cancer cell survival.

There are 11 NDA Classification Codes.

Escient Pharmaceuticals Commences First Human Study for EP262, a Novel Oral Drug Blocking MRGPRX2, Aimed at Treating Eczema.

CBER continues to monitor the safety and stability of biological products that have been approved.

Based on previous studies, biomarker analysis from Phase 1/2 study of tusamitamab ravtansine (SAR408701) in patients with advanced non-small cell lung cancer (NSCLC) was reported at the AACR Congress.

Due to HDAC’s fundamental role in gene expression and its different effects on histones and non-histones, HDAC has become an ideal target for the treatment of various malignant tumors. HDAC inhibitors are considered one of the most promising anti-cancer drugs.

TOLREMO Initiates Phase 1 Study by Administering TT125-802 to Initial Participant, an Innovative Compound Targeting Transcriptional Resistance in Cancer Treatment.

Death is not an AE because it is a final outcome of the patient's condition, rather than an adverse event itself.

Recent results presented at the AACR Congress show the benefit of durvalumab with chemotherapy, then as an adjuvant, in resectable NSCLC patients, confirming immunotherapy's effectiveness in both neoadjuvant and adjuvant stages.

The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.

Aldeyra Therapeutics, Inc. has disclosed that it has received a Complete Response Letter from the FDA regarding the New Drug Application of reproxalap.