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RSS FeedPosted by Michael Wonder on 07 Sep 2019
European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer
6 September 2019 - Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved by ...
Posted by Michael Wonder on 07 Sep 2019
Lonsurf (trifluridine/tipiracil) receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer
6 September 2019 - Servier and its partner Taiho Pharmaceutical announced today that the European Commission has approved the use ...
Posted by Michael Wonder on 07 Sep 2019
Endo announces submission of biologics license application to FDA for collagenase clostridium histolyticum in patients with cellulite
6 September 2019 - Endo International announced today that the Company has submitted a biologics license application to the ...
Posted by Michael Wonder on 07 Sep 2019
FDA approves first treatment for patients with rare type of lung disease
6 September 2019 - The U.S. FDA today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary ...
Posted by Michael Wonder on 07 Sep 2019
Ridgeback Biotherapeutics announces receipt of breakthrough therapy designation from FDA for mAb114
6 September 2019 - Ridgeback Biotherapeutics today announced that the FDA has recently granted mAb114, an experimental treatment for Ebola, ...
Posted by Michael Wonder on 06 Sep 2019
Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer
6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019. ...
Posted by Michael Wonder on 05 Sep 2019
FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated ...
Posted by Michael Wonder on 05 Sep 2019
Is the FDA out to get this $2.9 billion diabetes drug class?
6 September 2019 - In March, the FDA issued a complete response letter -- the agency's euphemism for a rejection ...
Posted by Michael Wonder on 05 Sep 2019
GBT announces U.S. FDA acceptance of new drug application and priority review for voxelotor for the treatment of sickle cell disease
5 September 2019 - NDA supported by data from Phase 3 HOPE study, which demonstrated statistically significant and sustained improvements in ...
Posted by Michael Wonder on 05 Sep 2019
Texas Doctor Stephen M. Hahn is a top contender to head FDA
4 September 2019 - M.D. Anderson’s radiation-oncology chief is among three leading candidates for post open since April. ...
Posted by Michael Wonder on 05 Sep 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
4 September 2019 - European approval based on KEYNOTE-426 trial results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 05 Sep 2019
$32 million available to support vital translational health
5 September 2019 - The Australian Government is opening the door for Australian researchers through a $32 million investment that will ...
Posted by Michael Wonder on 05 Sep 2019
European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union
4 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission has approved the ...
Posted by Michael Wonder on 05 Sep 2019
Tricida announces submission of new drug application for veverimer for the treatment of metabolic acidosis in patients with chronic kidney disease
4 September 2019 - New drug application submitted under the FDA’s accelerated approval program. ...
Posted by Michael Wonder on 04 Sep 2019
Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders
4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...