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4743 News Found

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients


Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution
Drug Approval | August 25, 2022

Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution

Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US


Glenmark  receives OAI communication from US FDA
Drug Approval | August 24, 2022

Glenmark receives OAI communication from US FDA

The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest


Unichem Laboratories receives ANDA approval for Carbamazepine Tablets
Drug Approval | August 24, 2022

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets

Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia


Celanese announces Grant Award to develop refillable drug delivery solution
News | August 24, 2022

Celanese announces Grant Award to develop refillable drug delivery solution

Celanese to conduct research, prototype development and characterization of a refillable contraceptive technology with award from the Bill & Melinda Gates Foundation


Lonza introduces X-ray powder diffraction at Monteggio
News | August 23, 2022

Lonza introduces X-ray powder diffraction at Monteggio

This rapid analytical technique provides additional information about the polymorph and solid-state properties of active pharmaceutical ingredients (APIs)


Wockhardt signs USFDA approved manufacturing partners
Drug Approval | August 22, 2022

Wockhardt signs USFDA approved manufacturing partners

The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA