⚡ Top Events Today
FDA Approves Regeneron's Otarmeni, First-Ever Gene Therapy for Genetic Hearing Loss
The FDA approved Otarmeni, the first dual adeno-associated virus (AAV) vector-based gene therapy, for a rare type of inherited hearing loss.
AbbVie's Botox Competitor Rejected by FDA on Manufacturing Concerns
The FDA issued a Complete Response Letter (CRL) for AbbVie's BLA for its prospective Botox competitor, citing manufacturing process issues. No new clinical studies were requested.
Sanofi's Tolebrutinib Gains CHMP Backing in Europe for MS After US Rejection
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended tolebrutinib for approval in Europe for certain MS patients, following an FDA complete response letter in December.
MSD Gains FDA Approval for New Once-Daily HIV Drug, Idvynso
The FDA approved Idvynso, a new once-daily combination drug for the treatment of HIV. Analysts forecast potential blockbuster sales.
FDA Approves First Generic Versions of AstraZeneca's Blockbuster SGLT2 Inhibitor Farxiga
The FDA approved the first generic versions of dapagliflozin, the active ingredient in AstraZeneca's Farxiga.
📁 All Events (13984 stories)
The FDA rejected two new products from AbbVie and Grace Therapeutics due to manufacturing-related concerns. One of the rejected products from AbbVie was described as a prospective Botox offering.
The FDA rejected two new products from AbbVie and Grace Therapeutics due to manufacturing-related concerns. One of the rejected products from AbbVie was described as a prospective Botox offering.
The US Food and Drug Administration (FDA) has approved the first generic versions of dapagliflozin. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, also known by its brand name Farxiga.
The US Food and Drug Administration (FDA) has approved the first generic versions of dapagliflozin. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, also known by its brand name Farxiga.
Sanofi's tolebrutinib has received CHMP backing for approval in Europe for certain multiple sclerosis patients. This development follows a complete response letter from the FDA in December.
Sanofi's tolebrutinib has received CHMP backing for approval in Europe for certain multiple sclerosis patients. This development follows a complete response letter from the FDA in December.
The U.S. Food and Drug Administration (FDA) has approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. This therapy is approved for the treatment of genetic hearing loss and was granted under the National Priority Voucher Program.
The U.S. Food and Drug Administration (FDA) has approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. This therapy is approved for the treatment of genetic hearing loss and was granted under the National Priority Voucher Program.
Sanofi has received FDA approval for Tzield. This approval allows the drug to be used to delay the onset of stage 3 type 1 diabetes in children as young as one year old who have been diagnosed with stage 2 type 1 diabetes.
Sanofi has received FDA approval for Tzield. This approval allows the drug to be used to delay the onset of stage 3 type 1 diabetes in children as young as one year old who have been diagnosed with stage 2 type 1 diabetes.
Cipla Limited and its subsidiary Cipla USA Inc. announced on April 23, 2026, that they received final U.S. FDA approval for their first AB-rated generic of Ventolin® HFA.
Cipla Limited and its subsidiary Cipla USA Inc. announced on April 23, 2026, that they received final U.S. FDA approval for their first AB-rated generic of Ventolin® HFA.
Regeneron's gene therapy Otarmeni has received the first-ever FDA approval for a rare type of inherited hearing loss. The company intends to provide the treatment for free in the US.
Regeneron's gene therapy Otarmeni has received the first-ever FDA approval for a rare type of inherited hearing loss. The company intends to provide the treatment for free in the US.
AbbVie received a Complete Response Letter (CRL) from the U.S. FDA for its Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE). The FDA's decision was related to manufacturing processes, and no additional clinical studies were requested.
AbbVie received a Complete Response Letter (CRL) from the U.S. FDA for its Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE). The FDA's decision was related to manufacturing processes, and no additional clinical studies were requested.
The FDA has approved MSD's once-daily HIV combination drug, Idvynso. GlobalData analysts forecast a blockbuster future for Idvynso, though they note it is unlikely to displace market dominator Biktarvy.
The FDA has approved MSD's once-daily HIV combination drug, Idvynso. GlobalData analysts forecast a blockbuster future for Idvynso, though they note it is unlikely to displace market dominator Biktarvy.
Roche's Enspryng achieved a phase 3 victory, demonstrating a 68% reduction in relapse risk for patients with the rare autoimmune disorder MOGAD. This positive outcome suggests that a first-of-its-kind FDA approval for the neuroinflammatory disease may be imminent.
Roche's Enspryng achieved a phase 3 victory, demonstrating a 68% reduction in relapse risk for patients with the rare autoimmune disorder MOGAD. This positive outcome suggests that a first-of-its-kind FDA approval for the neuroinflammatory disease may be imminent. | Endpoints: relapse_risk_reduction
The FDA has approved a once-daily HIV pill from Merck. This approval allows Merck to enter the HIV treatment market.
The FDA has approved a once-daily HIV pill from Merck. This approval allows Merck to enter the HIV treatment market.
Marketing authorisations were granted in 2026.
Marketing authorisations were granted in 2026.
The FDA has approved a wearable device for the treatment of pancreatic cancer. This approval was published online in Nature Biotechnology on April 17, 2026.
The FDA has approved a wearable device for the treatment of pancreatic cancer. This approval was published online in Nature Biotechnology on April 17, 2026.
The US Food and Drug Administration (FDA) has approved insulin icodec-abae, marketed as Awiqli. This marks the first once-weekly basal insulin treatment option for adults with type 2 diabetes.
The US Food and Drug Administration (FDA) has approved insulin icodec-abae, marketed as Awiqli. This marks the first once-weekly basal insulin treatment option for adults with type 2 diabetes.
The US Food and Drug Administration (FDA) approved the oral GLP-1 receptor agonist orforglipron, marketed as Foundayo, for daily use in people with overweight or obesity. Unlike other oral GLP-1 drugs, orforglipron can be taken any time of day without food or water restrictions.
The US Food and Drug Administration (FDA) approved the oral GLP-1 receptor agonist orforglipron, marketed as Foundayo, for daily use in people with overweight or obesity. Unlike other oral GLP-1 drugs, orforglipron can be taken any time of day without food or water restrictions.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in stock value. Consequently, a securities class action lawsuit has been filed against the company and an executive. The lawsuit represents investors who acquired Gossamer securities between June 16, 2025, and February 20, 2026.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in stock value. Consequently, a securities class action lawsuit has been filed against the company and an executive. The lawsuit represents investors who acquired Gossamer securities between June 1
Revolution Medicines announced positive Phase 3 results for its pancreatic cancer treatment. This win caused the company's buyout price to soar, despite a previously rumored $30 billion buyout offer no longer being active.
Revolution Medicines announced positive Phase 3 results for its pancreatic cancer treatment. This win caused the company's buyout price to soar, despite a previously rumored $30 billion buyout offer no longer being active.
Travere's drug for a kidney disease received FDA approval. This approval occurred despite the clinical trial results indicating that the drug did not improve kidney function, which disappointed expectations.
Travere's drug for a kidney disease received FDA approval. This approval occurred despite the clinical trial results indicating that the drug did not improve kidney function, which disappointed expectations.