Approvals

Merck gets FDA nod for Keytruda to treat BCG-unresponsive, high-risk NMIBC

Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).

Ipsen gets UK approval for Dysport to treat upper limb spasticity in children with cerebral palsy

Biopharmaceutical company Ipsen has secured approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its Dysport as a symptomatic treatment for upper limb spasticity in children with cerebral palsy.

AstraZeneca, Merck secure FDA nod for pancreatic cancer drug Lynparza

AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib) as a first-line maintenance treatment for germline BRCA-mutated metastatic pancreatic cancer.

Roche’s Kadcyla gets EC nod as adjuvant treatment for HER2-positive early breast cancer

Roche has secured approval from the European Commission (EC) for its Kadcyla (trastuzumab emtansine) as an adjuvant (after surgery) treatment for people with HER2-positive early breast cancer (eBC).

Astellas, Seattle Genetics get FDA’s accelerated approval for bladder cancer drug Padcev

Astellas Pharma and Seattle Genetics have secured accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) to treat people with locally advanced or metastatic urothelial cancer.

EC grants orphan drug status to Dicerna’s DCR-A1AT to treat congenital A1AT deficiency

Dicerna Pharmaceuticals has secured orphan drug designation from the European Commission (EC) for its DCR-A1AT to treat congenital alpha-1 antitrypsin (A1AT) deficiency.

Pfizer, Astellas secure expanded FDA approval for XTANDI

Pfizer and Astellas Pharma have secured approval for a new indication for XTANDI (enzalutamide) from the US Food and Drug Administration (FDA) to include its use in metastatic castration-sensitive prostate cancer (mCSPC).

Meitheal Pharmaceuticals announces FDA approval of Enoxaparin Sodium Injection, USP

Meitheal Pharmaceuticals, a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox.

Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

Bristol-Myers Squibb (BMS) has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Orencia (abatacept) to prevent moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.