Regulation

Faeth’s PIKTOR plus paclitaxel combo gains FDA fast track status

Faeth Therapeutics has received the US Food and Drug Administration’s (FDA) fast track designation for the sapanisertib and serabelisib (PIKTOR) with paclitaxel combination to treat advanced or recurrent endometrial cancer.

EMA validates Pfizer and Valneva’s Lyme disease vaccine

The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.

FDA grants fast track status to Phanes’ spevatamig for advanced BTC

Phanes Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for spevatamig to treat patients with advanced and metastatic biliary tract carcinoma (BTC).

BMS secures FDA accelerated approval for Zenbexus in multiple myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS) Zenbexus (iberdomide), along with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd), to treat adult multiple myeloma (MM) patients.

Akeso secures China NMPA authorisation for ivonescimab combo

Summit Therapeutics’ partner Akeso has secured China’s National Medical Products Administration (NMPA) authorisation for the use of ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC) patients.

Amgen’s Repatha receives positive CHMP opinion for broader cardiovascular use

Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Repatha (evolocumab) supporting its broader use prior to a first heart attack or stroke.

FDA grants fast track designation for HAYA Therapeutics’ HTX-001

HAYA Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational therapy, HTX-001, to treat symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

FDA grants fast track designation for Lundbeck’s Lu AH69593

Lundbeck has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational treatment, Lu AH69593, to treat narcolepsy.

Affinia Therapeutics receives FDA orphan drug designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) orphan drug designation for AFTX-201, a treatment in development for BAG3-associated dilated cardiomyopathy (DCM).