Blog
RSS FeedPosted by Michael Wonder on 07 Apr 2022
Innovent announces the approval of Pemazyre (pemigatinib) by the NMPA for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy
6 April 2022 - Innovent Biologics announced that the National Medical Products Administration has approved Pemazyre (pemigatinib) for the treatment of ...
Posted by Michael Wonder on 04 Apr 2022
JW Therapeutics announces receipt of breakthrough therapy designation for Carteyva in mantle cell lymphoma in China
3 April 2022 - JW Therapeutics announced that the Center for Drug Evaluation of the National Medical Products Administration of China ...
Posted by Michael Wonder on 28 Mar 2022
China approves Takeda cancer drug
25 March 2022 - Japanese pharmaceutical company Takeda announced on Friday that brigatinib, an innovative lung cancer drug, has been approved ...
Posted by Michael Wonder on 21 Mar 2022
China’s NMPA grants greater access to rheumatology biosimilars
22 March 2022 - Since the start of 2022, China’s National Medicinal Products Agency has made strides to increase greater ...
Posted by Michael Wonder on 14 Mar 2022
InnoCare announces acceptance of supplemental new drug application for orelabrutinib in relapsed or refractory Waldenström's macroglobulinemia in China
14 March 2022 - InnoCare Pharma announced today that the Center for Drug Evaluation of the China National Medical Products Administration ...
Posted by Michael Wonder on 14 Mar 2022
China NMPA approves tislelizumab for patients with microsatellite instability-high or mismatch repair-deficient solid tumours
11 March 2022 - Tislelizumab is now approved in seven indications in China. ...
Posted by Michael Wonder on 28 Feb 2022
JW Therapeutics announces NMPA acceptance of the supplemental new drug application for Carteyva in patients with relapsed or refractory follicular lymphoma
27 February 2022 - JW Therapeutics announced that the National Medical Products Administration of China accepted the supplemental new drug ...
Posted by Michael Wonder on 12 Feb 2022
China approves use of Pfizer's COVID drug Paxlovid
12 February 2022 - China's medical products regulator said on Saturday it has given conditional approval for Pfizer's COVID-19 drug ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...
Posted by Michael Wonder on 06 Feb 2022
Importing oncology trials from China: a bridge over troubled waters?
4 February 2022 - On 10 February 2022, the US FDA's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a ...
Posted by Michael Wonder on 31 Jan 2022
Trevena announces submission of new drug application in China for Olinvyk by its partner Jiangsu Nhwa Pharmaceutical
27 January 2022 - Submission supported by data from a Phase 3 bridging study of oliceridine injection compared to intravenous morphine, ...
Posted by Michael Wonder on 30 Jan 2022
BeiGene announces acceptance of supplemental new drug application in China for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia with breakthrough therapy designation
28 January 2022 - Brukinsa was granted its first breakthrough therapy designation in China with this application. ...
Posted by Michael Wonder on 19 Jan 2022
CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration
17 January 2022 - Priority review expected to be granted. ...
Posted by Michael Wonder on 16 Jan 2022
Basilea announces approval of antifungal Cresemba (isavuconazole) for invasive aspergillosis in China
13 January 2022 - Second approved indication after invasive mucormycosis in December 2021. ...
Posted by Michael Wonder on 27 Dec 2021
Ligand’s Partner CStone Pharmaceuticals receives approval in China for sugemalimab (Cejemly) for the first-line treatment of advanced non-small-cell lung cancer in combination with chemotherapy
22 December 2021 - Sugemalimab was discovered using the OmniAb platform. ...