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RSS FeedPosted by Michael Wonder on 06 Apr 2021
Statement by Acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adjunct Professor John Skerritt
2 April 2021 - Australia's vaccine safety and regulatory process is world class and people can be confident that vaccines ...
Posted by Michael Wonder on 06 Apr 2021
Biofrontera submits application for FDA approval of new BF-RhodoLED XL lamp
31 March 2021 - Biofrontera today announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy ...
Posted by Michael Wonder on 06 Apr 2021
Acadia Pharmaceuticals receives complete response letter from U.S. FDA for supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
5 April 2021 - Acadia Pharmaceuticals today announced that the Company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 06 Apr 2021
Kite submits supplemental biologics license application to U.S. FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukaemia
1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients ...
Posted by Michael Wonder on 06 Apr 2021
United Therapeutics announces FDA approval and launch of Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease
1 April 2021 - First and only approved therapy in the United States for patients with PH-ILD, a serious, life-threatening ...
Posted by Michael Wonder on 05 Apr 2021
BeyondSpring announces submission of new drug application to U.S. FDA and China NMPA for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
31 March 2021 - Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers ...
Posted by Michael Wonder on 05 Apr 2021
Supernus announces FDA approval of Qelbree (SPN-812) for the treatment of ADHD
2 April 2021 - Qelbree (viloxazine extended release capsules) represents the first novel non-stimulant treatment for ADHD in a decade. ...
Posted by Michael Wonder on 05 Apr 2021
FDA approvals strengthen Octapharma USA paediatric critical care product portfolio
30 March 2021 - Octaplas and fibryga receive new product labeling following FDA’s approval of BLA supplements to update therapy ...
Posted by Michael Wonder on 05 Apr 2021
Copikta (duvelisib) receives positive CHMP opinion for the treatment of relapsed and refractory CLL and refractory FL
1 April 2021 - Secura Bio announced that the CHMP of the EMA adopted a positive opinion recommending the approval of ...
Posted by Michael Wonder on 03 Apr 2021
Autolus Therapeutics receives PRIME designation for AUTO1 for the treatment of adult ALL
1 April 2021 - Autolus Therapeutics today announced that it has received PRIority MEdicines (PRIME) designation from the EMA for AUTO1, ...
Posted by Michael Wonder on 03 Apr 2021
Taltz (ixekizumab) approved by Health Canada for the treatment of paediatric patients (six to less than 18 years of age) with moderate to severe plaque psoriasis
2 April 2021 - On 29 March 2021, Health Canada issued a Notice of Compliance for Taltz (ixekizumab) injection, 80 mg/mL, ...
Posted by Michael Wonder on 02 Apr 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of moderate to severe atopic dermatitis
2 April 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 01 Apr 2021
FDA grants breakthrough therapy designation for Taiho Oncology's futibatinib for treatment of advanced cholangiocarcinoma
1 April 2021 - Taiho Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for futibatinib (TAS-120), a ...
Posted by Michael Wonder on 01 Apr 2021
European Commission approves Cabometyx in combination with Opdivo as a first-line treatment for patients living with advanced renal cell carcinoma
31 March 2021 - Approval based on pivotal Phase 3 CheckMate-9ER trial data, also recently published in the New England Journal ...
Posted by Michael Wonder on 31 Mar 2021
Merck receives positive EU CHMP opinion for updated label of Keytruda (pembrolizumab) to include results of Phase 3 KEYNOTE-361 trial in certain adult patients with locally advanced or metastatic urothelial cancer
30 March 2021 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending that the ...