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MHRA approves for Epidyolex® (cannabidiol) for TSC seizure treatment europeanpharmaceuticalreview
August 13, 2021
GW Pharmaceuticals received approval for Epidyolex®(cannabidiol) for the treatment of seizures linked to tuberous sclerosis complex (TSC) in the UK.
UK Regulators Recall Batches of “Sartan” Drug for Azido Impurities americanpharmaceuticalreview
August 13, 2021
The UK Medicines and Healthcare products Agency (MHRA) is recalling 25 batches of irbesartan-containing products as a precautionary measure due to contamination with an azido impurity, which the agency says has mutagenic potential.
MHRA nod for Janssen’s relapsing multiple sclerosis drug Ponvory pharmatimes
August 12, 2021
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Ponvory (ponesimod) for the treatment relapsing multiple sclerosis (RMS).
KYOWA, Bora Pharmaceuticals Enter Mfg. Pact contractpharma
August 11, 2021
Upon approval in Japan, Bora will be the commercial manufacturing site for the generic product production.
AZ’s Forxiga gains EC, MHRA approvals for chronic kidney disease pharmatimes
August 09, 2021
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the European Commission for the treatment of chronic kidney disease (CKD) in the European Union (EU).
MHRA approves Opdivo plus Yervoy for unresectable malignant pleural mesothelioma pharmatimes
August 06, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb's (BMS) Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for the first-line treatment of adult patients with unresectable malignant pleural ...
KYOWA Pharmaceutical Industry Co. Ltd. Partners with Bora Pharmaceuticals to Manufacture Generic Product for Filing in Japan prnasia
August 05, 2021
KYOWA Pharmaceutical Industry Co. Ltd., a premier Japanese pharmaceutical company, has contracted with Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals for the manufacturing of generic product for filing in Japan.
Hummingbird Bioscience Announces UK MHRA Approval for First-in-Human Phase 1 Trial of HMBD-001 in Advanced Cancers prnasia
August 02, 2021
Hummingbird Bioscience today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the clinical trial application (CTA) to initiate first-in-human phase 1 trial of HMBD-001 in patients with advanced cancers.
Merck’s MET inhibitor tepotinib gains positive opinion from MHRA pharmatimes
July 16, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion for Merck’s tepotinib for the treatment of advanced non-small cell lung cancer (NSCLC) with METex14 skipping alterations.
MHRA approves over-the-counter contraceptive pill pharmatimes
July 12, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a reclassification of HRA Pharma’s contraceptive pill, making it available to buy in the UK without a prescription.

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