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RSS FeedPosted by Michael Wonder on 05 Feb 2019
Pain Therapeutics announces feedback from recent meeting with FDA on Remoxy
5 February 2019 - Going Forward, We Will Be Silent Regarding Future Expectations for REMOXY. ...
Posted by Michael Wonder on 04 Feb 2019
Evolus receives FDA approval for Jeuveau prabotulinumtoxina-xvfs for injection
1 February 2019 - Jeuveau is the first aesthetic-only neurotoxin approved in the U.S; launch planned for spring 2019. ...
Posted by Michael Wonder on 04 Feb 2019
Alkermes receives complete response letter from U.S. FDA for ALKS 5461 new drug application
1 February 2019 - Alkermes today announced that it received a complete response letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 01 Feb 2019
Sunovion receives complete response letter from FDA for apomorphine sublingual film (APL-130277)
30 January 2019 - Sunovion Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 31 Jan 2019
FDA expands Lilly's Alimta (pemetrexed) label with combination of Keytruda (pembrolizumab) and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer
31 January 2019 - New approval based on Phase 3 KEYNOTE-189 results. ...
Posted by Michael Wonder on 30 Jan 2019
FDA approves first generic Advair Diskus
30 January 2019 - The U.S. FDA today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation ...
Posted by Michael Wonder on 28 Jan 2019
AbbVie announces U.S. FDA approval of Imbruvica (ibrutinib) plus obinutuzumab (Gazyva) - first chemotherapy-free, anti-CD20 combination regimen approved for chronic lymphocytic leukaemia/small lymphocytic lymphoma in previously untreated patients
28 January 2019 - FDA approval is based on positive Phase 3 iLLUMINATE (PCYC-1130) study results, which demonstrated Imbruvica plus obinutuzumab ...
Posted by Michael Wonder on 24 Jan 2019
FDA approves use of 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) in children as young as 6 months of age
23 January 2019 - The 0.5 mL dose is now approved for use in children 6 months through 35 months of ...
Posted by Michael Wonder on 22 Jan 2019
Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies
22 January 2019 - It's not accepting new applications or fees during the shutdown. ...
Posted by Michael Wonder on 19 Jan 2019
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
19 January 2019 - The U.S. FDA said on Friday it had approved a biosimilar to Roche’s blockbuster breast cancer ...
Posted by Michael Wonder on 18 Jan 2019
Lilly reports results of Phase 3 soft tissue sarcoma study of Lartruvo
18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a ...
Posted by Michael Wonder on 18 Jan 2019
Immunomedics receives complete response letter from FDA for sacituzumab govitecan biologics license application
17 January 2019 - Immunomedics today announced it has received a complete response letter from the U.S. FDA for the ...
Posted by Michael Wonder on 18 Jan 2019
Actelion receives complete response letter from U.S. FDA for Opsumit (macitentan) supplemental new drug application
16 January 2019 - Actelion today announced it has received a complete response letter from the U.S. FDA for its supplemental ...
Posted by Michael Wonder on 16 Jan 2019
FDA approves first generic version of Sabril to help treat seizures in adults and paediatric patients with epilepsy
16 January 2019 - The U.S. FDA approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex ...
Posted by Michael Wonder on 16 Jan 2019
Amneal announces approval of rivastigmine transdermal system
14 January 2019 - Amneal Pharmaceuticals today announced that it has received FDA approval for a generic version of Exelon Patch ...