A quick review of drug approval in the past 2019 by NMPA, EMA and FDA.
NMPA
NMPA approves a total of 53 new drugs in 2019, Including 39 imported new drugs and 14 domestic new drugs, 33 of them are chemical medicine, 14 are biopharmaceuticals, 4 are vaccines and 2 are Chinese Traditional Medicines.
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EMA
2019 Sees Decline In EMA Drug Approval Recommendations. The number of positive opinions given by the EMA’s CHMP has fallen to 66 this year from 84 in 2018.
Authorization of New Medicines in 2019
Source: EMA official website
FDA
In 2019, the US Food & Drug Administration (FDA) approved 48 new molecular entities (NMEs), lower than the 59 NMEs approved in 2018.
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According to offical website of FDA, here is a list of pharmaceutical products approved by FDA in 2019:
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 48. | Ubrelvy | ubrogepant | 12/23/2019 | to treat acute treatment of migraine with or without aura in adults |
| 47. | Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | To treat metastatic breast cancer |
| 46 | Dayvigo | lemborexant | 12/20/2019 | To treat insomnia |
| 45. | Caplyta | lumateperone tosylate | 12/20/2019 | To treat schizophrenia |
| 44. | TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery |
| 43. | Padcev | enfortumab vedotin-ejfv | 12/18/2019 | To treat refractory bladder cancer |
| 42. | Vyondys 53 | golodirsen | 12/12/2019 | To treat certain patients with Duchenne muscular dystrophy |
| 41. | Oxbryta | voxelotor | ...
Read More
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