recent pharma news

Lexicon Announces FDA Approval of INPEFA (Sotagliflozin) For Treatment of Heart Failure Lexicon Pharmaceuticals, Inc. announced that the FDA has approved INPEFATM (sotagliflozin), a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure vis...

FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease AbbVie announced that the FDA had approved RINVOQ® (upadacitinib) for treating people with moderately to highly active Crohn's disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. Thi...

FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...

FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...

RegeneRx Biopharmaceuticals Enrolled First Patient in the Phase 3 Neurotrophic Keratitis Clinical Trial with RGN-259 in the US On April 12, 2023, RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company") announced that the first patient of Phase 3 clinical trial (SEER-2) of RGN-259, a novel treat...

Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to ...

AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...

FDA Approves BeiGene’s Brukinsa for CLL/SLL BeiGene's Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been approved by the US Food and Drug Administration. CLL is a common type of leukemia, accounting for approximately 25% of all new cases each year. SLL is...

Ipsen to Acquire Albireo for USD 952 Million Ipsen, a French pharmaceutical company, has offered USD 42 per share for the US biotech Albireo and its rare disease treatment Bylvay, continuing a recent spree of merger and acquisition activity. Albireo, a Boston-based business, is valued at USD 952 million under th...