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Pharma News

FDA Offers Advice on Macular Degeneration Drug Trials
FDA Offers Advice on Macular Degeneration Drug Trials

The FDA outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draf

t guidance.
FDA Accepts IND and Grants Priority Review for SpringWorks Desmoid Tumors Therapeutic
FDA Accepts IND and Grants Priority Review for SpringWorks Desmoid Tumors Therapeutic
The U.S. Food and Drug Administration has accepted for Priority Review SpringWorks Therapeutics’ New Drug Application for nirogacestat, an investigational gamma secretase inhibitor, for the treat...
Dr. Reddy's bolsters US generics business with $105M deal to buy Mayne Pharma assets
Dr. Reddy's bolsters US generics business with $105M deal to buy Mayne Pharma assets
More generic products will soon join the fold at Dr. Reddy’s Laboratories as the drugmaker has agreed to spend up to $105 million to purchase Mayne Pharma’s U.S. copycats portfolio. ...
FDA Approves Sanofi and Sobi’s Altuviiio for Hemophilia A
FDA Approves Sanofi and Sobi’s Altuviiio for Hemophilia A
The FDA has approved Sanofi and Sobi’s Altuviiio for adults and children with Hemophilia A, for use in prophylaxis, perioperative management during surgery and on-demand treatment to control blee...
First-of-its-kind study examines the impact of cannabis use on surgical patients' post-procedure healthcare needs
First-of-its-kind study examines the impact of cannabis use on surgical patients' post-procedure healthcare needs
As legislation in multiple states eases former restrictions around medical and recreational cannabis in the United States, an increasing proportion of the population reports use of the drug. Betwe...
FDA creates task force to fast track COVID-19 drugs registration
FDA creates task force to fast track COVID-19 drugs registration

The Food and Drug Administration (FDA) has created a task force to fast track and streamline the approval and evaluation of COVID-19 drug

s in the country.
Alzheimer’s Antibody Therapy from Eli Lilly Granted US FDA Breakthrough Therapy designation
Alzheimer’s Antibody Therapy from Eli Lilly Granted US FDA Breakthrough Therapy designation
Donanemab, Eli Lilly and Company’s investigational antibody therapy for Alzheimer's disease (AD), has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA).&nbs...
EU Authorizes CSL’s Gene Therapy for Hemophilia B
EU Authorizes CSL’s Gene Therapy for Hemophilia B
The European Commission has granted a conditional marketing authorization for CSL’s Hemgenix (etranacogene dezaparvovec) as the first EU-approved gene therapy for treatment of  Hemophilia B....
Theravance, Viatris Seek to Block Copies of COPD Drug
Theravance, Viatris Seek to Block Copies of COPD Drug
Theravance Biopharma and Viatris have alleged that multiple drugmakers infringed on their patent protections for Yupelri (revefenacin) — a long-acting bronchodilator used to treat chronic obstru...
FDA Approves Austedo XR Extended-Release Tablets for Huntington’s Disease
FDA Approves Austedo XR Extended-Release Tablets for Huntington’s Disease
The FDA approved deutetrabenazine extended-release tablets (Austedo XR, Teva Pharmaceuticals) for adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). ...
Cognition Therapeutics and ACTC Receive FDA Clearance for Phase 2 START Study of Oral CT1812 in Early Alzheimer’s Disease
Cognition Therapeutics and ACTC Receive FDA Clearance for Phase 2 START Study of Oral CT1812 in Early Alzheimer’s Disease
Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that it has cleared the U.S. Food and Drug Administration comment period and may now proceed with the 540-patient Phase 2 START study of CT1812...
FDA Approves First Treatment for Geographic Atrophy, Accepts NDA for Same Indication
FDA Approves First Treatment for Geographic Atrophy, Accepts NDA for Same Indication
The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection as the first approved therapy to treat geographic atrophy secondary to age-related macular degeneration, a leading ...
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