Regulatory

Sentynl Therapeutics’ Nulibry (fosdenopterin) Gains the MHRA’s Approval to Treat Molybdenum Cofactor Deficiency (MoCD) Type A

Sentynl Therapeutics’ Nulibry (fosdenopterin) Gains the MHRA’s Approval to Treat Molybdenum Cofactor Deficiency (MoCD) Type A

Shots: The MHRA has approved Sentynl’s (wholly-owned by Zydus Lifesciences)...

NovelMed’s NM5072 Receives the US FDA’s Orphan Drug Designation to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

NovelMed’s NM5072 Receives the US FDA’s Orphan Drug Designation to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The US FDA has granted orphan drug designation to the company’s NM507...

The US FDA Accepts GSK’s BLA of Meningococcal ABCWY Vaccine for Invasive Meningococcal Disease (IMD)

The US FDA Accepts GSK’s BLA of Meningococcal ABCWY Vaccine for Invasive Meningococcal Disease (IMD)

Shots: The US FDA has accepted the BLA of 5-in-1 meningococcal ABCWY (MenABCWY) va...

The US FDA Grants Orphan Drug Designation to Candel Therapeutics’ CAN-2409 as a Treatment for Pancreatic Cancer

The US FDA Grants Orphan Drug Designation to Candel Therapeutics’ CAN-2409 as a Treatment for Pancreatic Cancer

Shots: The company’s CAN-2409 has received the US FDA’s orphan drug de...

PureTech’s LYT-200 Gains the US FDA’s Fast Track Designation for Treating Head and Neck Cancers

PureTech’s LYT-200 Gains the US FDA’s Fast Track Designation for Treating Head and Neck Cancers

Shots: The US FDA has granted FTD to LYT-200, human IgG4 mAb targeting galectin-9,...

AstraZeneca and Daiichi Sankyo’s Enhertu Receives the US FDA’s Accelerated Approval to Treat Metastatic HER2-Positive Solid Tumors

AstraZeneca and Daiichi Sankyo’s Enhertu Receives the US FDA’s Accelerated Approval to Treat Metastatic HER2-Positive Solid Tumors

Shots: The approval was supported by 3 P-II studies assessing the safety & eff...

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