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RSS FeedPosted by Michael Wonder on 19 Oct 2021
Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. FDA
19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 ...
Posted by Michael Wonder on 19 Oct 2021
New medicine for breast cancer approved by the TGA
19 October 2021 - Enhertu has been approved for provisional registration. ...
Posted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 19 Oct 2021
Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age
18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...
Posted by Michael Wonder on 18 Oct 2021
US FDA approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 18 Oct 2021
United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application
18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning. ...
Posted by Michael Wonder on 18 Oct 2021
Omeros receives complete response letter from FDA for biologics license application for narsoplimab in the treatment of HSCT-TMA
18 October 2021 - Omeros Corporation today announced that the company received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 18 Oct 2021
Revance provides regulatory update on daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar (frown) lines
15 October 2021 - Revance Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 18 Oct 2021
Oyster Point Pharma announces FDA approval of Tyrvaya (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry eye disease
18 October 2021 - Tyrvaya is the first and only nasal spray approved for the treatment of the signs and symptoms ...
Posted by Michael Wonder on 18 Oct 2021
EMA grants PRIME designation for JR-141 for the treatment of mucopolysaccharidosis type II (Hunter syndrome)
18 October 2021 - JCR Pharmaceuticals announced today that the EMA has granted PRIME designation for the investigational drug JR-141 (pabinafusp ...
Posted by Michael Wonder on 18 Oct 2021
Australia secures additional COVID-19 treatments
17 October 2021 - The Australian Government has secured access to two additional COVID-19 treatments to support the National Plan to ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves naloxone injection to counteract opioid overdoses
18 October 2021 - The FDA has approved Zimhi (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
18 October 2021 - The U.S. FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. ...