Regulation

Merck receives complete response letter from FDA for sBLAs for KEYTRUDA six-week dosing schedule

Merck said that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding its supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.

ALX Oncology’s ALX148 receives two fast track designations from FDA

ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations for its lead candidate, ALX148, for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma.

PharmaMar, Jazz get FDA priority review for lurbinectedin in relapsed SCLC

PharmaMar and Jazz Pharmaceuticals have secured priority review for their synthetic compound lurbinectedin from the US Food and Drug Administration (FDA) for its use in relapsed small cell lung cancer (SCLC).

FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the US

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).

Ascletis’ IND filing for its NASH drug accepted by NMPA

Ascletis Pharma announces the application for in-house developed Category 1 Drug ASC41 for clinical trials of NASH indication has been accepted by China's National Medical Products Administration (NMPA).

Novartis gets EC nod for Beovu to treat wet AMD

Novartis has secured approval from the European Commission (EC) for its Beovu (brolucizumab) to treat wet age-related macular degeneration (AMD).

Epizyme seeks FDA accelerated approval for Tazverik to treat follicular lymphoma

Epizyme is seeking accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat patients with relapsed or refractory follicular lymphoma (FL).

Seattle Genetics gets FDA priority review for tucatinib in locally advanced or metastatic HER2-positive breast cancer

Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the investigational medicine tucatinib.

The US FDA accepts for priority review Bristol-Myers Squibb’s BLA for liso-cel for adult patients with relapsed or refractory large B-cell lymphoma

Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.