📁 All Events (14421 stories)
Alumis is exploring strategic alternatives for its drug program, a potential rival to Amgen's Tepezza. The company has decided to halt the program and will not pursue the previously envisaged Phase 3 development.
Alumis is exploring strategic alternatives for its drug program, a potential rival to Amgen's Tepezza. The company has decided to halt the program and will not pursue the previously envisaged Phase 3 development.
Aardvark Therapeutics plans to unblind data from its phase 3 Prader-Willi syndrome program. This decision comes after the FDA imposed a full clinical hold on the company's studies.
Aardvark Therapeutics plans to unblind data from its phase 3 Prader-Willi syndrome program. This decision comes after the FDA imposed a full clinical hold on the company's studies.
The FDA approved Tecentriq's label expansion for post-surgical bladder cancer. This approval was granted alongside Natera's Signatera, which will serve as a companion diagnostic.
The FDA approved Tecentriq's label expansion for post-surgical bladder cancer. This approval was granted alongside Natera's Signatera, which will serve as a companion diagnostic.
On May 15, 2026, the FDA approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) by Genentech, Inc. These drugs are approved as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA.
On May 15, 2026, the FDA approved atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) by Genentech, Inc. These drugs are approved as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA.
The FDA approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) as the first interchangeable biosimilars to Simponi and Simponi Aria (golimumab), respectively. These biosimilars are indicated for the treatment of rheumatoid arthritis and ulcerative colitis.
The FDA approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) as the first interchangeable biosimilars to Simponi and Simponi Aria (golimumab), respectively. These biosimilars are indicated for the treatment of rheumatoid arthritis and ulcerative colitis.
The article highlights ongoing accelerated approvals for drugs and biologics. These approvals target non-malignant hematological, neurological, and other disorder indications and are based on surrogate endpoints.
The article highlights ongoing accelerated approvals for drugs and biologics. These approvals target non-malignant hematological, neurological, and other disorder indications and are based on surrogate endpoints.
Aardvark's rare disease trial has been placed on a full clinical hold by the FDA. The company plans to unblind the trial data following this regulatory action.
Aardvark's rare disease trial has been placed on a full clinical hold by the FDA. The company plans to unblind the trial data following this regulatory action.
Kyowa Kirin has secured FDA approval for a dosing update to the Crysvita prescribing information. This update introduces a new dosing option for adults with X-linked hypophosphatemia (XLH).
Kyowa Kirin has secured FDA approval for a dosing update to the Crysvita prescribing information. This update introduces a new dosing option for adults with X-linked hypophosphatemia (XLH).
Ratura Oncology received a positive recommendation from its Safety Review Committee to continue the Cardioprotection and Anticancer Synergy (CPACS) study. This Phase 3 clinical trial is evaluating a treatment for advanced solid tumor patients.
Ratura Oncology received a positive recommendation from its Safety Review Committee to continue the Cardioprotection and Anticancer Synergy (CPACS) study. This Phase 3 clinical trial is evaluating a treatment for advanced solid tumor patients.
On May 15, 2026, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of adults with HER2-positive early-stage breast cancer.
On May 15, 2026, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of adults with HER2-positive early-stage breast cancer.
Regenxbio's gene therapy for Duchenne muscular dystrophy successfully met its primary endpoint in a pivotal trial. This positive outcome marks a significant win for the company, which has faced recent challenges including an FDA rejection and clinical hold.
Regenxbio's gene therapy for Duchenne muscular dystrophy successfully met its primary endpoint in a pivotal trial. This positive outcome marks a significant win for the company, which has faced recent challenges including an FDA rejection and clinical hold.
Four cancer drugs received FDA approval in May. These approvals cover both haematological and solid tumour indications.
Four cancer drugs received FDA approval in May. These approvals cover both haematological and solid tumour indications.
BeOne has received FDA approval for the treatment of lymphoma. This marks a significant regulatory milestone for the drug.
BeOne has received FDA approval for the treatment of lymphoma. This marks a significant regulatory milestone for the drug.
AstraZeneca reported positive Phase 3 results for its drug Imfinzi, used alongside Padcev, in bladder cancer patients who were cisplatin-ineligible. This follows a prior FDA approval for Imfinzi in muscle-invasive bladder cancer patients eligible for cisplatin-based chemotherapy.
AstraZeneca reported positive Phase 3 results for its drug Imfinzi, used alongside Padcev, in bladder cancer patients who were cisplatin-ineligible. This follows a prior FDA approval for Imfinzi in muscle-invasive bladder cancer patients eligible for cisplatin-based chemotherapy.
BeOne Medicines received US accelerated FDA approval for its next-gen BCL2 inhibitor, sonrotoclax. The drug is approved for a rare and aggressive form of blood cancer, where it will compete with Venclexta.
BeOne Medicines received US accelerated FDA approval for its next-gen BCL2 inhibitor, sonrotoclax. The drug is approved for a rare and aggressive form of blood cancer, where it will compete with Venclexta.
On May 13, 2026, the FDA granted accelerated approval to sonrotoclax (Beqalzi), a BCL-2 inhibitor from BeOne Medicines USA, Inc. This approval is for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy.
On May 13, 2026, the FDA granted accelerated approval to sonrotoclax (Beqalzi), a BCL-2 inhibitor from BeOne Medicines USA, Inc. This approval is for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy.
The article highlights the impact of TIL therapies on cancer research, noting that the first TIL therapy received FDA approval two years ago. It prompts an inquiry into the current state of the field following this significant regulatory milestone.
The article highlights the impact of TIL therapies on cancer research, noting that the first TIL therapy received FDA approval two years ago. It prompts an inquiry into the current state of the field following this significant regulatory milestone.
Lupin Limited announced on May 13, 2026, that it received approval from the United States Food and Drug Administration (FDA) for its Famotidine Injection, USP. This approval marks a significant regulatory milestone for the global pharmaceutical leader.
Lupin Limited announced on May 13, 2026, that it received approval from the United States Food and Drug Administration (FDA) for its Famotidine Injection, USP. This approval marks a significant regulatory milestone for the global pharmaceutical leader.
On May 13, 2026, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax. This approval is for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or those with comorbidities.
On May 13, 2026, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax. This approval is for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or those with comorbidities.
Alkermes announced that its sodium oxybate drug, Lumryz, met all primary and key secondary endpoints in a Phase 3 study for a rare sleep disorder. This clinical success follows Alkermes' $2.37 billion acquisition of Avadel.
Alkermes announced that its sodium oxybate drug, Lumryz, met all primary and key secondary endpoints in a Phase 3 study for a rare sleep disorder. This clinical success follows Alkermes' $2.37 billion acquisition of Avadel.